Quality Assurance Specialist (External Filling)

Role: QA Specialist focusing on external drug product filling operations at Regeneron, responsible for ensuring compliance in dispositioning products and raw materials. Responsibilities: review and approve batch and master batch records, support deviations, change controls, CAPAs, and investigations; liaise with external partners on QA policies and regulatory communication; train and mentor junior staff; perform raw material and product disposition activities; review controlled documents and participate in investigations; evaluate processes for continuous improvement. Requirements: B.S. in life sciences or related field (or equivalent experience); 4+ years for Specialist, 6+ years for Senior level in QA or related roles. HighValue: cGMP compliance, external filling operations, batch documentation review, deviation and CAPA management, regulated environment. WorkSetup: onsite in East Greenbush, NY; travel ~5% domestic.