Senior QA Specialist - QC Lab Operations

Winston-Salem, North Carolina, United States Position Summary The Quality Assurance Specialist III supports Quality oversight of the Analytical and Microbiology Laboratories within a fast-paced, regulated cell therapy manufacturing environment. This role ensures compliance with cGMP, regulatory expectations, internal quality standards, and industry best practices. The Specialist serves as a key QA liaison to both labs, providing elevated level review, technical assessment, issue resolution, and continuous improvement support for testing activities that ensure product quality, patient safety, and data integrity. Primary Responsibilities Provide Quality Assurance oversight of daily operations within the Analytical and Microbiology laboratories to ensure full compliance with cGMP, regulatory expectations, and internal quality standards. Review and approve laboratory data packages, including analytical raw data, microbiological test results, environmental monitoring results, and associated documentation for completeness, accuracy, and data integrity (including audit trail review). Serve as QA reviewer for analytical and microbiology-related deviations, OOS/OOT investigations, EM excursions, and other laboratory events. Assess and approve change controls relating to laboratory methods, instrumentation, workflows, and controlled documents. Perform routine GxP walkthroughs of laboratory areas, identify compliance gaps, document observations, and ensure timely resolution. Review and approve method validation protocols/reports, equipment qualification documents, and relevant SOPs. Provide QA representation during internal audits, regulatory inspections, and laboratory readiness activities. Act as QA subject matter expert (SME) for analytical testing, microbiological methods, and quality expectations related to cell therapy products. Pull QC samples from the LN2 and store IPC samples within the LN2. Support training and mentoring of QC staff on quality principles, documentation standards, and deviation/OOS/OOT/CAPA management. Collaborate cross-functionally with QC labs, Manufacturing, Quality Systems, ASAT and Regulatory Affairs to support efficient sample testing and product release. Participate in continuous improvement initiatives to enhance data integrity, streamline workflow, and strengthen laboratory compliance. Contribute to risk assessments related to laboratory operations, equipment, and method lifecycle activities. Review lab system entries, electronic data workflows, and lab system upgrades. Provide QA input during method transfers, new assay implementation, and introduction of new laboratory equipment or technologies. Requirements Bachelor’s degree in Life Sciences, Microbiology, Chemistry, Biotechnology, or a related scientific field required. Advanced degree (MS) preferred but not required. Minimum of 5 years of QA or QC experience in a regulated biopharmaceutical, cell therapy, biologics, or sterile manufacturing environment. Demonstrated familiarity with analytical methods (e.g., flow cytometry, qPCR, ELISA) and microbiological techniques (e.g., sterility, endotoxin, bioburden, mycoplasma, EM). Prior experience reviewing laboratory data under cGMP required. Experience supporting or leading laboratory investigations (deviations, OOS, OOT, EM excursions). Strong working knowledge of cGMP, 21 CFR Parts 210/211, Part 1271, ICH guidelines, and data integrity (ALCOA+) principles. Understanding of laboratory instrumentation, method validation, equipment qualification, and change control processes. Experience with electronic systems such as LIMS, Empower, or other data acquisition platforms is preferred. Excellent attention to detail and strong decision-making skills. Ability to independently manage multiple priorities in a fast-paced, dynamic environment. Strong communication skills to partner effectively with laboratory, manufacturing, and quality teams. Ability to analyze technical data, identify compliance risks, and propose sound corrective actions. 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. Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship. #J-18808-Ljbffr ProKidney