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Senior Quality Assurance Specialist, On the floor (Overnights)

Regeneron
August 20, 2026
Full-time
On-site
East Greenbush, NY
Operations
Role: Senior QA Specialist supporting drug product start-up and operations at Regeneronโ€™s East Greenbush facility, focusing on quality assurance initiatives across formulation, filling, inspection, assembly, and packaging processes. Responsibilities: develop and review SOPs and specifications, assess procedures, perform on-floor quality reviews, support audits and investigations, and contribute to continuous improvement projects. The role involves mentorship during manufacturing, material quarantine, and line clearance activities, with flexibility to adjust schedules based on manufacturing needs. Requirements: B.S. in life sciences or related field with 6+ years of relevant experience; proven expertise in GxP environments, preferably in biologics or drug product manufacturing. High-Value: supports biologics or small molecule drug products, with involvement in scale-up, process validation, and compliance activities; 3rd shift operations; physical capacity for cleanroom gowning and environment. WorkSetup: on-site in East Greenbush, New York, with physical and shift-specific demands.