Senior QA Specialist - QC Lab Operations

<p>&nbsp;</p> <p><strong>Position Summary:</strong></p> <p>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.</p> <p>&nbsp;</p> <p>This is located onsite in Winston Salem, NC.</p> <p>&nbsp;</p> <p><strong>Essential Duties &amp; Responsibilities:</strong></p> <ul> <li>Provide QA oversight for Analytical and Microbiology laboratory operations in alignment with cGMP requirements, internal procedures, and applicable regulatory expectations.</li> <li>Review and approve documentation, including (but not limited to): <ul> <li>Method lifecycle documentation, including method qualification, validation, transfer, and periodic review for both microbiological and analytical assays.</li> <li>QC laboratory equipment and instrument life cycle documentation, including IQ/OQ/PQ, calibration strategies, and associated change controls.</li> <li>Review and approve analytical equipment CSV protocols and final reports.</li> <li>SOPs</li> </ul> </li> <li>Review and support laboratory quality events, including deviations, OOS/OOT investigations, EM excursions, laboratory incidents, and associated CAPA activities.</li> <li>Ensure compliance with data integrity principles, ALCOA+ expectations, and applicable electronic record/electronic signature requirements.</li> <li>Review and approve laboratory change controls, risk assessments, CAPAs, and protocol/report packages related to QC systems, instruments, and methods.</li> <li>Conduct routine GxP walkthroughs of QC laboratory areas to identify compliance risks, reinforce procedural adherence, and support inspection readiness.</li> <li>Serve as QA representative during internal audits, and regulatory inspections related to QC laboratory operations.</li> <li>Partner with leadership and cross-functional stakeholders to drive timely resolution of quality issues and support continuous improvement of laboratory quality systems.</li> <li>Provide mentoring, technical guidance, and quality oversight to junior staff as needed, without direct people-management responsibility.</li> &l