Principal Quality Assurance Reviewer

Role: Principal QA Specialist/Reviewer supporting Regeneron's Fill Finish manufacturing at Rensselaer, NY, focusing on compliance, investigations, and quality oversight. Responsibilities: independently review and approve investigations into non-conformances, OOS/OOT lab results, and supplier corrective actions; coach investigation teams; analyze investigation data, trends, and process data; present quality findings to management; ensure data accuracy per cGMP standards; monitor production processes; lead cross-functional study teams; train employees on investigation techniques; coordinate multi-department meetings. Qualifications: BS/BA in Life Sciences, Engineering, or related field; 8+ years (Principal level) or 10+ years (Staff level) relevant experience; sterile drug product manufacturing, fill finish, or QC testing experience. HighValue: sterile drug manufacturing, fill finish, investigations, cGMP compliance, quality oversight. WorkSetup: onsite in Rensselaer, NY, Monday-Friday 8am-4:30pm.