{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5073337007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4602461007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5073337007,"updated_at":"2026-04-07T13:43:49-04:00","requisition_id":"PRO-676","title":"Associate Director, Validation","company_name":"ProKidney","first_published":"2026-03-12T15:05:48-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA’s guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Continuously improving the culture of the Validation team and the site\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct support to OST head or lead annual OPEX budget for Validation department\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Staff and System Development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Effective delegation and building confidence and competence within direct reports\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive engagement in the technical and personal development of the Validation team and members\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Champion and enhance the culture of the Validation team\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree. Preferred Fields of Study: Life Sciences or Engineering\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 5 years in a leadership role\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of Validation Lifecycle (GAMP 5) principles\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with calibration and maintenance management software\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of electronic document management systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with data integrity practices and compliance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong technical writing skills for qualification documents, SOPs, and work instructions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple projects simultaneously with minimal supervision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Detail-oriented with excellent verbal and written communication abilities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to adapt to changing priorities in a deadline-oriented environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in writing computer system test scripts, validation protocols and summary reports\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033631007,"name":"Validation","child_ids":[],"parent_id":4033618007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5042266007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4588192007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5042266007,"updated_at":"2026-03-16T13:10:55-04:00","requisition_id":"PRO-660","title":"Manager, QA Floor Support","company_name":"ProKidney","first_published":"2026-02-03T22:04:12-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Quality Assurance On-The-Floor (OTF) Manager is responsible for leading the QA On-The-Floor team and providing real-time quality oversight of clinical and commercial manufacturing activities at ProKidney’s cGMP site. Reporting to the VP of Quality, this role managers daily floor support operations, ensures compliance with GMP and regulatory requirements, and partners closely with Manufacturing, Quality Control, Supply Chain, and Facilities to maintain a state of control on the production floor.\u0026lt;br\u0026gt;This position is located fully onsite in Winston Salem, NC.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Team Leadership \u0026amp;amp; Oversight\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Manage, develop, and coach the QA On-the-Floor team; ensure training, qualification, and performance expectations are met.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assign and approve work performed by direct reports, including documentation reviews and floor support activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain team readiness by ensuring all OTF personnel remain gown-qualified and trained on current procedures.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Manufacturing Floor Support \u0026amp;amp; Quality Oversight\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Oversee and publish daily/weekly QA floor support schedules aligned with the manufacturing schedule.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide real-time QA presence on the manufacturing floor, including routine walkthroughs, observation of operations, support during processing, and reinforcement of cleanroom behaviors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, document, and escalate GMP issues or atypical events during manufacturing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform and/or oversee real-time batch record review to ensure accuracy and completeness.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Quality Decision Making \u0026amp;amp; Issue Resolution\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Make routine QA decisions related to room/equipment release, line clearance, and documentation accuracy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support and/or approve alarms, return-to-service documentation, deviations, change controls, and other quality records related to floor operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Manufacturing to troubleshoot operational issues and implement corrective actions.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Documentation \u0026amp;amp; Compliance Activities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ensure timely review of GMP documents (forms, logbooks, testing documentation, alarms, kitting, etc.).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure quarantined materials are stored and managed appropriately post-manufacturing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author, revise, and review SOPs and quality procedures related to on-the-floor operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support internal audits, regulatory inspections, and compliance initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Cross Functional Collaboration\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Collaborate in a fast-paced, matrixed environment to ensure alignment on quality expectations and operational priorities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in cross-functional quality teams and process improvement initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Other Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Maintain standards for accurate documentation, data integrity, and compliance in all QA-OTF activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform other duties as assigned.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Education And Experience:\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in applied science or related field.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;5+ years relevant QA experience in cGMP aseptic manufacturing, preferred as Quality on the floor\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven, hands-on knowledge of commercial GMP regulations for sterile manufacturing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organizational, analytical, and time management skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work well in a team environment with positive attitude.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication skills with strong attention to detail.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to handle multiple tasks simultaneously.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated working knowledge of FDA, EU, and ICH regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Physical ability to perform frequent tasks requiring strength and mobility.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033642007,"name":"Quality Management","child_ids":[],"parent_id":4033620007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5112095007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4620169007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5112095007,"updated_at":"2026-04-28T09:37:56-04:00","requisition_id":"PRO-699","title":"Manufacturing Cell Processing Specialist 2","company_name":"ProKidney","first_published":"2026-04-28T09:37:56-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;The Manufacturing Specialist II, Cell Processing at ProKidney plays a critical role in supporting advanced manufacturing operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves setting up, operating, and maintaining production equipment, including control rate freezers and orbital shakers, performing final product freezing and storage, and providing guidance to junior staff while leading improvements in cell processing operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Duties \u0026amp;amp; Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead and participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.\u0026lt;br\u0026gt;• Read, understand, and implement Standard Operating Procedures (SOPs) for all assigned tasks, providing guidance to other team members as needed.\u0026lt;br\u0026gt;• Set up, operate, and troubleshoot production equipment such as control rate freezers, orbital shakers, etc., ensuring optimal performance and maintaining preventive maintenance schedules.\u0026lt;br\u0026gt;• Perform final freezing and storage of cell therapy products in LN2, ensuring adherence to specified procedures and quality standards.\u0026lt;br\u0026gt;• Revise, update, and ensure adherence to approved documents, including SOPs, batch records, and MS forms, maintaining GMP compliance.\u0026lt;br\u0026gt;• Ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, adhering to Good Documentation Practices (GDP).\u0026lt;br\u0026gt;• Train and mentor junior team members in cell processing techniques, procedures, and cGMP compliance.\u0026lt;br\u0026gt;• Perform and support investigations into deviations, incidents, and process improvements.\u0026lt;br\u0026gt;• Lead efforts in process development, qualification, and validation activities as needed.\u0026lt;br\u0026gt;• Ensure all activities comply with safety policies, rules, and regulations, and promote a safe working environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Secondary Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead and assist in material qualification tests to ensure the suitability of manufacturing materials.\u0026lt;br\u0026gt;• Provide guidance and support for continuous process improvement initiatives.\u0026lt;br\u0026gt;• Assist in data collection, analysis, and reporting for process optimization and regulatory submissions.\u0026lt;br\u0026gt;• Perform other duties as assigned to support and improve manufacturing operations.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Minimum Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Education/Training:\u0026lt;/strong\u0026gt; AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.\u0026lt;br\u0026gt;• \u0026lt;strong\u0026gt;Experience:\u0026lt;/strong\u0026gt; Preferred minimum 2-4 years of relevant experience in cell processing, biotechnology manufacturing, or a related field, with at least 1-2 years of proven expertise in a cGMP-regulated environment.\u0026lt;br\u0026gt;• \u0026lt;strong\u0026gt;Skills/Abilities:\u0026lt;/strong\u0026gt; Ability to exercise independent judgment, lead teams, and ensure compliance with cGMPs. Strong computer skills, including Microsoft Office, and expertise in ERP systems, along with advanced organizational, record-keeping, and time management skills.\u0026lt;br\u0026gt;• \u0026lt;strong\u0026gt;Other:\u0026lt;/strong\u0026gt; Strong problem-solving skills, effective written and oral communication, a team-oriented approach, and a commitment to high-quality work are critical for success in this role.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033618007,"name":"Manufacturing \u0026 Operations","child_ids":[4033632007,4033631007,4033633007,4047045007,4033638007,4033636007,4033621007,4049249007,4033635007,4033637007,4033634007,4047046007],"parent_id":null}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5081556007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4606133007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5081556007,"updated_at":"2026-03-26T12:00:01-04:00","requisition_id":"PRO-682","title":"Manufacturing Cell Processing Team Lead","company_name":"ProKidney","first_published":"2026-03-18T16:08:17-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Team Lead, Cell Processing serves as a technical resource within the manufacturing team, supporting daily cell processing operations in a cGMP-regulated environment. This role provides on-the-floor guidance to manufacturing staff, supports execution of cell processing activities, and assists the Shift Manufacturing Supervisor with coordination of production activities. The Team Lead functions as a leader in manufacturing processes, promotes adherence to cGMP and aseptic techniques, and contributes to operational consistency, training, and continuous improvement.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is located onsite in Winston Salem, NC.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Duties \u0026amp;amp; Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide on-the-floor leadership and technical guidance during cell processing operations, supporting the manufacturing team in executing production activities safely and\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a technical guide for cell processing operations, including cell culture, expansion, harvesting, formulation, and cryopreservation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support coordination of daily manufacturing activities to ensure alignment with the production schedule and operational priorities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist in task coordination and workflow organization during manufacturing operations to support efficient execution of batch activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform complex or critical manufacturing steps in a cleanroom environment in accordance with cGMP and aseptic processing requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support troubleshooting of process or equipment issues and escalate concerns to the Manufacturing Supervisor when appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with review of batch documentation, logbooks, and manufacturing records to ensure accuracy and adherence to Good Documentation Practices (GDP).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the development and training of manufacturing personnel on cell processing techniques, SOPs, and cleanroom practices.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to deviation investigations, CAPA activities, and process improvements by providing technical input and operational knowledge.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with implementation or revision of manufacturing procedures, batch records, and documentation as processes evolve.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in daily tier meetings and communicate operational updates, risks, or resource needs to the Supervisor.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain compliance with safety procedures, cGMP regulations, and internal quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support audit readiness and participate in inspections as\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform other duties as assigned to support manufacturing\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Minimum Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Education/Training\u0026lt;/strong\u0026gt;: AS/BS in Biotechnology, Biology, Chemistry, or equivalent; preferred area of study in a Science-related discipline. High School Diploma or Equivalent with relevant experience may be considered.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;: Preferred minimum 4 years of relevant experience in biotechnology manufacturing or a related field.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Skills/Abilities\u0026lt;/strong\u0026gt;: Proficiency in biological processing techniques such as cell culture, ultra-filtration, and column Advanced knowledge of cGMP facilities and requirements. Strong organizational skills with the ability to manage multiple projects and meet deadlines. Critical thinking ability and judgment to make appropriate decisions within defined procedures.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Other\u0026lt;/strong\u0026gt;: Excellent eye/hand coordination, effective written and oral communication skills, team-oriented with a strong work ethic.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033633007,"name":"Manufacturing","child_ids":[],"parent_id":4033618007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5130703007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4628862007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5130703007,"updated_at":"2026-05-18T22:12:03-04:00","requisition_id":"PRO-706","title":"Manufacturing Support Supervisor","company_name":"ProKidney","first_published":"2026-05-07T21:00:07-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;The Manufacturing Support Supervisor provides front-line supervision for the manufacturing support function, ensuring safe, compliant, and reliable execution of daily operations in accordance with cGMP requirements. This role coordinates core support activities including media preparation, material kitting, and GMP cleaning to enable on-time manufacturing execution by following the approved schedule and standard work. The supervisor assigns daily work, supports training and qualification compliance, addresses routine operational issues, and escalates constraints, deviations, and staffing concerns to management as appropriate. This position partners with Manufacturing, Quality, Supply Chain, Training, and Facilities to maintain operational continuity and serves as a floating supervisor, providing supervisory coverage for the Cell Processing team as needed.\u0026lt;br\u0026gt;Supervision \u0026amp;amp; Leadership\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide day-to-day supervision and guidance for the manufacturing support team, reinforcing safe, efficient, and compliant execution of assigned operations\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Assign and coordinate daily workload and priorities across media preparation, material kitting, GMP cleaning, and related support activities to meet production demand\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintain routine floor presence and conduct shift huddles to communicate priorities, monitor progress, and reinforce standard work and cGMP behaviors\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide coaching and on-the-job guidance; document observations and communicate recurring performance concerns to management/HR for follow-up as needed\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Promote a culture of safety, quality, and accountability through clear expectations, timely feedback, and consistent follow-through\u0026lt;br\u0026gt;Production \u0026amp;amp; Scheduling\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Coordinate end-of-day cleaning activities to support next-day readiness; ensure tasks are executed and documented and communicate any missed activities and recovery needs\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Coordinate daily/weekly support execution (materials, media, and cleaning) to align with the production plan; communicate readiness and issues to the appropriate stakeholders\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Partner with the Manufacturing Scheduler to align priorities and communicate schedule impacts and constraints; support mitigation actions as directed\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Coordinate shift coverage (including time-off coverage) and communicate coverage risks to management; support coverage plans to minimize impact to operations\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support timely task execution by removing routine barriers, adjusting priorities within the shift, and escalating issues that may impact schedule adherence\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Track and communicate shift performance items (e.g., completion status, documentation issues, and safety/quality observations) and escalate recurring issues for corrective action\u0026lt;br\u0026gt;Manufacturing Compliance\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide daily floor-level quality oversight for the support team by reinforcing procedures, safety expectations, and Quality System requirements\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Verify manufacturing documentation is completed correctly and on time, including Batch Records and Electronic Batch Records (EBRs); coordinate timely correction of errors and coaching to prevent recurrence\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Review batch records, SOPs, and logbooks for accuracy and completeness; route documentation per procedure and promptly escalating discrepancies to Quality and Manufacturing management\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support internal and external audits and inspections by ensuring documentation readiness for the shift and by completing assigned follow-up actions within required timelines\u0026lt;br\u0026gt;System \u0026amp;amp; Documentation Management:\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Perform and verify accurate ERP transactions supporting manufacturing execution (e.g., material requisitions/allocation, production tracking, and work order updates)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Oversee documentation-related workstreams (labels, EBR updates, media and materials requests), ensuring prioritization, accuracy, and on-time completion\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Author and updated controlled documents (e.g., SOPs, deviations, protocols) in alignment with GMP requirements; route completed documents for review and approval through the appropriate Quality Systems workflow\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure training records are current and audit-ready; verify team compliance with required curricula, certifications, and role-based qualification plans\u0026lt;br\u0026gt;Continuous Improvement \u0026amp;amp; Operational Efficiency\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with cross-functional stakeholders to identify operational risks, capacity constraints, and resource needs; escalate findings and support mitigation plans as directed\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Coordinate evaluation and implementation of new materials and equipment by defining user requirements, supporting trials, and confirming readiness for GMP use\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintain visibility to improvement ideas, deviations/operational issues, and employee concerns; track progress and escalate unresolved items to leadership\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate in and support continuous improvement activities (standardization, 5S, waste reduction, error-proofing) to improve safety, quality, and cycle time\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate in cross-functional projects as a team representative to support manufacturing support capability and business continuity\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;Team Development \u0026amp;amp; Training\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide training support for material kitting and cleaning (as a trainer and/or by coordinating with qualified trainers) to support consistent execution to approved procedures\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Coach employees on standard work and GMP expectations; reinforce good practices through routine observations and feedback\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Coordinate with Training to schedule and complete required curricula; identify training gaps and communicate needs and impacts to management\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Monitor training completion and communicate non-compliance or qualification risks; support recovery actions as directed\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support onboarding and orientation for new team members by coordinating training plans and documenting progress toward role qualification milestones\u0026lt;br\u0026gt;Administrative \u0026amp;amp; Communication Responsibilities\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Manage shift handoffs and coverage changes, assign daily responsibilities, and represent the team in daily/departmental communications as needed\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Communicate status, risks, and needs to the manager and partner departments to support timely issue resolution in a fast-paced manufacturing environment\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide clear, timely written communication (emails, shift updates, and documentation) to ensure alignment and traceability\u0026lt;br\u0026gt;Additional Responsibilities\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide supervisory coverage across manufacturing operations as needed to maintain safe, compliant, and uninterrupted execution\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure manufacturing areas remain clean and inspection-ready, including equipment staging, waste management, and housekeeping to established standards\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support initiatives that improve team performance against safety, quality, delivery, and compliance expectations; reinforce gains through standard work\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Perform other duties as assigned to support departmental objectives and changing business needs\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Qualifications\u0026lt;br\u0026gt;Education / Training\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Bachelor’s degree or equivalent experience in a related field (e.g., Life Sciences, Manufacturing, or Engineering)\u0026lt;br\u0026gt;Experience/Education\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;AS/BS in Biotechnology, Biology, Chemistry or equivalent\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Minimum 4+ years of experience in a manufacturing or GMP environment\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;2+ years of experience in lead, training, or coordination role\u0026amp;nbsp;\u0026lt;br\u0026gt;Knowledge/Skills\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong knowledge of GMP guidelines, safety protocols, and regulatory requirements\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with ERP systems (Sage X3 or similar) and document management systems\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Good communication, leadership, and problem-solving skills\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ability to work in a fast-paced environment while maintaining high standards of quality and compliance\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Technical writing experience is a plus (e.g., SOPs, deviation reports, protocols)\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033633007,"name":"Manufacturing","child_ids":[],"parent_id":4033618007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5149348007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4638097007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5149348007,"updated_at":"2026-05-29T16:33:55-04:00","requisition_id":"PRO-715","title":"Mfg Cell Processing Specialist 1","company_name":"ProKidney","first_published":"2026-05-29T16:33:55-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manufacturing Specialist, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of regenerative medicine therapies. This role involves setting up and operating production equipment, including control rate freezers, orbital shakers, and other equipment, while contributing to efficient processing, freezing, and storage of cell therapy products.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Duties \u0026amp;amp; Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Coordinate with team members and perform tasks with minimal supervision.\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Participate in cell processing activities, ensuring compliance with cGMP guidelines and ProKidney’s manufacturing standards.\u0026lt;br\u0026gt;• Set up and operate production equipment such as control rate freezers, orbital shakers, and other systems to support cell processing activities.\u0026lt;br\u0026gt;• Assist in processing, freezing, and storage of biologic and cell therapy products, ensuring adherence to cGMP standards.\u0026lt;br\u0026gt;• Accurately complete GMP documentation, including batch records, logbooks, and forms, ensuring compliance with Good Documentation Practices (GDP).\u0026lt;br\u0026gt;• Maintain inventory and monitor conditions related to biologic and cell therapy products, including temperature control, expiration dates, and equipment calibration.\u0026lt;br\u0026gt;• Ensure the accuracy and integrity of cell processing workflows, identifying deviations from established procedures and taking corrective actions as necessary.\u0026lt;br\u0026gt;• Collaborate with cross-functional teams to support process improvements, troubleshooting, and equipment maintenance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct aseptic manufacturing processes in a cleanroom environment, ensuring compliance with sterile techniques and regulatory standards.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Secondary Responsibilities and Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Assist in data collection, analysis, and reporting for process improvement initiatives.\u0026lt;br\u0026gt;• Support material qualification, process development, and validation efforts as required.\u0026lt;br\u0026gt;• Maintain compliance with all relevant safety policies, rules, and regulations.\u0026lt;br\u0026gt;• Perform other duties as assigned.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Minimum Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Education/Training:\u0026lt;/strong\u0026gt; AS/BS in Biotechnology, Biology, Chemistry, or related field; a Science-related discipline is preferred. Relevant experience may substitute for formal education. High School Diploma or Equivalent may be considered with significant relevant experience.\u0026lt;br\u0026gt;• \u0026lt;strong\u0026gt;Experience:\u0026lt;/strong\u0026gt; Preferred minimum 0-2 years of experience in cell processing, biotechnology manufacturing, or a related field. Experience with biologic or cell therapy production is highly desirable.\u0026lt;br\u0026gt;• \u0026lt;strong\u0026gt;Skills/Abilities:\u0026lt;/strong\u0026gt; Strong understanding of cGMP requirements, with proficiency in operating cell processing equipment. Ability to work independently or collaboratively, demonstrate attention to detail, and follow complex protocols. Strong organizational, record-keeping, and time management skills.\u0026lt;br\u0026gt;• \u0026lt;strong\u0026gt;Other:\u0026lt;/strong\u0026gt; Good eye/hand coordination, effective written and oral communication skills, a team-oriented approach, and a strong work ethic are essential for success.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033633007,"name":"Manufacturing","child_ids":[],"parent_id":4033618007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5112093007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4620168007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5112093007,"updated_at":"2026-04-22T21:35:03-04:00","requisition_id":"PRO-700","title":"Mfg Support Specialist 3","company_name":"ProKidney","first_published":"2026-04-22T21:35:03-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;The Manufacturing Support Specialist III plays a key leadership role in supporting manufacturing operations, with a primary focus on aseptic processing, GMP cleaning, and adherence to cGMP guidelines. This position requires a high level of expertise in performing complex aseptic processing of in-house solutions, preparing materials and kits, managing GMP areas, and ensuring stringent compliance with Standard Operating Procedures (SOPs). The role also involves actively participating in document revision, providing training and mentoring to junior staff, and assisting in deviation and CAPA (Corrective and Preventive Action) investigations. As a senior position, the Specialist III will be a key contributor to maintaining high standards of GMP documentation and will work with a high degree of accountability and independence to ensure the continuous improvement of manufacturing operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Aseptic Processing \u0026amp;amp; GMP Maintenance:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Perform aseptic processing of in-house solutions according to current cGMP guidelines, ensuring all processes maintain the highest standards of sterility and quality.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in material kit preparation, ensuring alignment with Good Documentation Practices (GDP) and cGMP standards.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform and oversee cleaning and sanitization of GMP areas and manufacturing equipment following approved cleaning procedures and industry best practices.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure proper documentation of cleaning and maintenance activities, including batch records and logbooks, in strict adherence to GMP and GDP standards.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the maintenance of the clean room environment, ensuring it remains below alert level limits and is consistently compliant with cleanliness standards.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Documentation \u0026amp;amp; Compliance:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Review, revise, and update SOPs, batch records, and other manufacturing documents to maintain compliance with current regulatory requirements and best practices.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Complete and ensure the accuracy of GMP documentation, including batch records, logbooks, and forms, in compliance with GDP.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in internal and external audits, supporting the team in ensuring compliance with regulatory bodies, including the FDA.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor and support compliance with GMP standards and assist with deviation investigations, ensuring corrective actions are implemented where necessary.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Training, Mentoring \u0026amp;amp; Leadership:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Mentor and train new and less experienced staff on manufacturing processes, GMP procedures, and safety protocols.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead by example to foster a culture of compliance and quality, ensuring all team members follow established guidelines and safety regulations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist in training initiatives for the broader team, focusing on aseptic techniques, GMP best practices, and proper documentation practices.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the continuous improvement of manufacturing processes and SOPs through participation in cross-functional meetings and projects.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Material \u0026amp;amp; Equipment Management:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Conduct routine cycle counts in cleanrooms to ensure accurate inventory levels and prevent shortages.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage and execute routine transactions in the ERP system, including material requisitions, production tracking, and inventory management.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure proper handling, storage, and documentation of materials and equipment to prevent contamination and maintain compliance with GMP standards.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Safety \u0026amp;amp; Process Improvement:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Promote and enforce adherence to safety policies and procedures to prevent workplace accidents and injuries.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proactively identify deviations from SOPs and GMP standards and take immediate corrective action.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist in the implementation of Corrective and Preventive Actions (CAPAs), identifying root causes of issues and ensuring solutions are effectively put in place.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support process optimization initiatives and work with teams to improve operational efficiencies while maintaining regulatory compliance.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Collaboration \u0026amp;amp; Data Collection:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with cross-functional teams, including production, quality assurance, and engineering, to ensure seamless operations and continuous adherence to manufacturing standards.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist in data collection efforts for troubleshooting, CAPA investigations, and other manufacturing-related tasks.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide insights and contribute to the development of new procedures, technologies, and improvements within manufacturing operations.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Secondary Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Perform additional tasks as needed to support the manufacturing team and ensure the smooth operation of the manufacturing process.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to data analysis and reporting efforts as directed.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Minimum Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education/Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;AS/BS in Biotechnology, Biology, Chemistry, or a related field; a Science-related discipline is preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High School Diploma or equivalent may be considered with relevant experience.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Certification in aseptic techniques or GMP training is preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;2-4 years of relevant experience in biotechnology manufacturing, GMP environments, or a related field.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience with aseptic techniques, GMP cleaning, and working in a regulated environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with SOP revision, documentation control, and deviation/CAPA investigations is preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills \u0026amp;amp; Abilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of cGMP and GDP standards, with the ability to follow production schedules and SOPs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in aseptic gowning, aseptic processing, and performing in a team-oriented environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High level of attention to detail and the ability to manage multiple tasks and priorities effectively.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong computer skills, including proficiency in Microsoft Office, ERP systems, and other relevant software tools.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent organizational, record-keeping, and time management abilities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to communicate effectively, both written and verbally, with a diverse team and in cross-functional environments.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to exercise independent judgment, solve problems, and identify improvements.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Other:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong eye/hand coordination and commitment to maintaining a high quality of work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A leadership mindset with the ability to mentor and train others.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Willingness to wear protective clothing and equipment as required in a GMP environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to lift and move objects up to [specific weight, e.g., 25 pounds].\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Physical Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ability to stand for extended periods and perform repetitive tasks.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Capability to lift and move objects up to [specific weight, e.g., 25 pounds].\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Willingness to wear protective clothing and equipment as required.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;\u0026amp;nbsp;\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033618007,"name":"Manufacturing \u0026 Operations","child_ids":[4033632007,4033631007,4033633007,4047045007,4033638007,4033636007,4033621007,4049249007,4033635007,4033637007,4033634007,4047046007],"parent_id":null}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5153167007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4639971007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5153167007,"updated_at":"2026-06-02T13:54:51-04:00","requisition_id":"PRO-714","title":"QC Analyst 3","company_name":"ProKidney","first_published":"2026-06-02T13:54:51-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Position Summary\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;The QC Analyst 3 will support various duties within the Quality Control (QC) department. This position plays a key role in ensuring the technical operations of QC, focusing on the technical suitability of bioanalytical test methods rather than day-to-day product testing. The role includes responsibility for the analytical method lifecycle, including method transfer, validation, compendial verification, performance monitoring, and continuous improvement, as well as ensuring analytical equipment is installed and qualified. The QC Analyst will support ProKidney’s pipeline, from Phase III clinical development through commercial operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• Writes and executes procedures for analytical method protocols, generating reports related to QC method transfer, validation, and verification.\u0026lt;br\u0026gt;• May write standard operating procedures (SOPs), protocols, and/or participate in instrument qualifications and analytical system validation.\u0026lt;br\u0026gt;• Support monitoring of analytical method performance, including assessment of analytical method system suitability requirements.\u0026lt;br\u0026gt;• Assist with data trending and aid in compilation of trend reports utilizing statistical tools.\u0026lt;br\u0026gt;• Work with internal departments to ensure system lifecycle document readiness and support analytical instrument qualification and system validation.\u0026lt;br\u0026gt;• Present to cross-functional teams and effectively communicate critical analytical issues and solutions.\u0026lt;br\u0026gt;• Familiarity with FDA and EMA guidance documents relevant to cell therapy, and compendial methods from USP and EP.\u0026lt;br\u0026gt;• Working knowledge of quality systems requirements.\u0026lt;br\u0026gt;• Ability to work in a fast-paced, collaborative environment, managing workload based on changing priorities.\u0026lt;br\u0026gt;• Demonstrated leadership skills and the ability to collaborate with and effectively influence others.\u0026lt;br\u0026gt;• Establish, revise, review, perform gap-assessment, and maintain procedures (including protocols and technical reports).\u0026lt;br\u0026gt;• Assure laboratory procedures are compliant with current requirements and facilitate updates as needed.\u0026lt;br\u0026gt;• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).\u0026lt;br\u0026gt;• Maintain QC lab and related systems to ensure compliance with industry standards and inspection readiness.\u0026lt;br\u0026gt;• Support CAPA’s, deviations, investigations, and OOS’s, ensuring effective resolution and continuous improvement.\u0026lt;br\u0026gt;• Other tasks as assigned.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• Bachelor’s degree or equivalent in Chemistry/Biochemistry, or a related discipline.\u0026lt;br\u0026gt;• Minimum of 5 years of relevant professional experience, including a combination of Quality Control, Analytical Development, or Microbiology. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed.\u0026lt;br\u0026gt;• Troubleshoot equipment and analytical testing methods.\u0026lt;br\u0026gt;• Prior experience with analytical method validations.\u0026lt;br\u0026gt;• Excellent technical writing skills.\u0026lt;br\u0026gt;• Familiar with ICH quality guidelines and their application in QC laboratory environments.\u0026lt;br\u0026gt;• Thorough understanding of industry testing requirements/standards.\u0026lt;br\u0026gt;• Excellent time management skills; organized and able to meet company deadlines.\u0026lt;br\u0026gt;• Ability to work and prioritize under pressure in an international environment.\u0026lt;br\u0026gt;• Familiar with FDA and EMA guidance documents relevant to gene therapy.\u0026lt;br\u0026gt;• Experience with Analytical Instrument Qualification and System Validation in laboratory environments.\u0026lt;br\u0026gt;• Familiarity with compendial methods including USP and EP.\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033632007,"name":"Quality Control","child_ids":[],"parent_id":4033618007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5136945007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4632038007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5136945007,"updated_at":"2026-05-18T16:36:48-04:00","requisition_id":"PRO-707","title":"QC Microbiology Analyst 3","company_name":"ProKidney","first_published":"2026-05-13T14:28:14-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;Join us in developing pioneering therapies that aim to transform the treatment of Chronic Kidney Disease (CKD) and change patients\u0026#39; lives. Our technology is designed to treat diseased kidneys using a patient\u0026#39;s own cells, potentially preventing or delaying the need for dialysis or transplant.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Quality Control (QC) Microbiology Analyst III provides support and execution on ProKidney’s Environmental Monitoring and Microbiological testing, maintaining GMP compliance, and mentoring junior analysts. This role involves monitoring during manufacturing operations, routine EM and utilities, root cause analysis of excursions, and documentation and continuous improvement within the QC Microbiology team. The Analyst III will work a 5/8 schedule (Sunday–Thursday or Monday-Friday), with weekend and holiday support. Shifts from either 0700–1600, 0800–1700 or 1030-1930.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Duties and Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Perform Change Control and CAPA investigations, ensuring timely closure, impact assessments, and regulatory compliance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support and internal and external audits.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generate and present metrics and trends for Management Review.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support training on Good Documentation Practices, Data Integrity, and Change Management.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and maintain SOPs, Work Instructions, Validation studies, Risk Assessments and protocols.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in continuous improvement initiatives, harmonization efforts, and risk assessments related to quality control.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform Routine Environmental Monitoring (EM) of classified GMP areas\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct Personnel Monitoring during Aseptic Manufacturing Operations and EMPQ activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Operate, maintain and troubleshoot EM and laboratory equipment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Adhere to Standard Operating Procedures (SOPs), Work Instructions (WIs), Protocols and safety requirements and document laboratory work consistent with cGMP requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in revising, and training on SOPs, WIs, Forms, and Protocols\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Supports lean initiatives in the area of lab operations, standard work, test method execution, documentation updates and equipment qualification\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Minimum Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education/Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in a science or technical discipline preferred, or equivalent experience.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;3-5 years of progressive experience in quality systems within regulated pharma, biotech, or medical device industries.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with commercial manufacturing and cleanroom monitoring strongly preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Knowledge:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong working knowledge of quality systems operations (Deviations, CAPA, Change Control, Training, Complaints, Document Control).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent technical writing, training, and communication skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Analytical mindset with ability to trend data and identify improvement opportunities.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong attention to detail and organizational skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work independently\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Competence with Microsoft Office (Excel, Word, Visio); LIMS or data tracking systems a plus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comfortable performing tasks in a cleanroom setting and wearing PPE for extended periods\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong written and verbal communication skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience with electronic QMS, particularly MasterControl (system administration and process ownership).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hand-on experience with LIMS or sample management programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to lift up to 30 pounds and maintain good hand-eye coordination. Bending, lifting and squatting required.\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033632007,"name":"Quality Control","child_ids":[],"parent_id":4033618007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5090092007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4609948007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5090092007,"updated_at":"2026-03-25T16:58:03-04:00","requisition_id":"PRO-688","title":"Quality Assurance Specialist 3, Floor Support","company_name":"ProKidney","first_published":"2026-03-25T16:58:03-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The \u0026lt;strong\u0026gt;Quality Assurance (QA) Specialist III\u0026lt;/strong\u0026gt; provides independent, real-time QA support within classified manufacturing areas, including cleanrooms. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance. The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role is an onsite position in Winston Salem, NC requiring full‑time presence in classified manufacturing environments. Due to the hands‑on, real‑time nature of quality activities, this role is not eligible for remote or hybrid work.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Duties \u0026amp;amp; Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide QA review of moderate‑complexity manufacturing operations in classified environments.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain continuous on‑floor presence to support compliance, production activities, and issue resolution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct complex in‑process batch record reviews and evaluate documentation for compliance and accuracy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review manufacturing records, environmental monitoring data, and related documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform and verify line clearance activities for assigned processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify, document, and resolve standard quality issues; escalate higher-risk or non-routine issues as required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support and contribute to deviation investigations, CAPAS, and remediation activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve facility alarms, work orders, and return‑to‑service documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in internal audits, inspections, and cross‑functional quality initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Follow all gowning, safety, and cleanroom behavior requirements.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education \u0026amp;amp; Experience Requirements\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in an applied science field or equivalent experience.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;5 years of QA experience in a GMP‑regulated manufacturing or quality environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Aseptic manufacturing experience preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Knowledge \u0026amp;amp; Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Solid professional knowledge of cGMP regulations and quality systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to apply judgement to moderately complex quality issues.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong documentation, analytical and problem-solving skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Effective cross-functional communication and collaboration.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple priorities with limited supervision.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;This position requires full‑time onsite work in a GMP manufacturing environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Not eligible for remote or hybrid work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Requires full gowning and extended time in cleanroom and classified areas.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to stand for extended periods and perform physical tasks as required.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033642007,"name":"Quality Management","child_ids":[],"parent_id":4033620007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/prokidney/jobs/5072148007","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":4601892007,"location":{"name":"Winston-Salem, North Carolina, United States"},"metadata":null,"id":5072148007,"updated_at":"2026-05-11T09:09:16-04:00","requisition_id":"PRO-674","title":"Senior QA Specialist - QC Lab Operations","company_name":"ProKidney","first_published":"2026-03-06T12:38:59-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior QA Validation Specialist, QC Laboratory Operations provides independent Quality Assurance oversight and compliance support for Analytical and Microbiology laboratory operations within a regulated autologous cell therapy manufacturing environment. This role exercises independent judgement on complex quality matters, ensuring QC validation activities are executed in accordance with applicable cGMP requirements, internal quality standards, and regulatory expectations, with specific emphasis on method qualification, equipment and instrument validation, data integrity, and inspection readiness. The QA Specialist partners closely with QC, Validation, and Quality Systems to maintain a robust state of control.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is located onsite in Winston Salem, NC.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Duties \u0026amp;amp; Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide QA oversight for Analytical and Microbiology laboratory operations in alignment with cGMP requirements, internal procedures, and applicable regulatory expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve documentation, including (but not limited to):\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Method lifecycle documentation, including method qualification, validation, transfer, and periodic review for both microbiological and analytical assays.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;QC laboratory equipment and instrument life cycle documentation, including IQ/OQ/PQ, calibration strategies, and associated change controls.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve analytical equipment CSV protocols and final reports.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;SOPs\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and support laboratory quality events, including deviations, OOS/OOT investigations, EM excursions, laboratory incidents, and associated CAPA activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure compliance with data integrity principles, ALCOA+ expectations, and applicable electronic record/electronic signature requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and approve laboratory change controls, risk assessments, CAPAs, and protocol/report packages related to QC systems, instruments, and methods.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct routine GxP walkthroughs of QC laboratory areas to identify compliance risks, reinforce procedural adherence, and support inspection readiness.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as QA representative during internal audits, and regulatory inspections related to QC laboratory operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with leadership and cross-functional stakeholders to drive timely resolution of quality issues and support continuous improvement of laboratory quality systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide mentoring, technical guidance, and quality oversight to junior staff as needed, without direct people-management responsibility.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Education/Training:\u0026lt;/strong\u0026gt; Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or related scientific discipline.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Experience:\u0026lt;/strong\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;8+ years of progressive QA or QC quality experience in a GMP-regulated pharmaceutical, biotech, or cell therapy environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience supporting microbiology and/or analytical QC laboratory operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience reviewing and supporting method qualification, validation, transfer, and lifecycle documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with laboratory instrument qualification/validation and associated change control processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of investigations, CAPA, deviations, and audit/inspection support.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated leadership in driving laboratory quality improvement initiatives and strategic quality initiatives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience influencing cross-functional decisions at the department or site level without direct authority\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Knowledge:\u0026lt;/strong\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of GMP regulations, including 21 CFR Parts 210/211, 11, and applicable FDA/EMA guidance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of Computer System Validation for analytical systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of cGMP requirements, laboratory quality systems, data integrity, and documentation practices.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with method qualification and/or validation (analytical and/or microbiological).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with laboratory instrument qualification/validation and computerized systems validation (CSV/CSA principles).\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Skills:\u0026lt;/strong\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with Laboratory Information Management Systems (LIMs), such as Labvantage, Empower, or similar laboratory systems.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong attention to detail and critical thinking skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to interpret regulatory requirements and apply them to complex QC processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Effective cross-functional communication and influence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organizational skills and the ability to manage multiple priorities in a fast-paced GMP environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Commitment to quality culture, compliance, and inspection readiness.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":4033632007,"name":"Quality Control","child_ids":[],"parent_id":4033618007}],"offices":[{"id":4029649007,"name":"Winston Salem, NC","location":"Winston-Salem, North Carolina, United States","child_ids":[],"parent_id":null}]}],"meta":{"total":11}}