QA Specialist, Drug Product

Role: QA Specialist supporting drug product manufacturing at Regeneron’s Rensselaer facility, focusing on start-up, validation, and ongoing quality assurance of formulation, filling, inspection, and packaging operations. Responsibilities: develop/review SOPs, perform on-floor quality reviews, support audits/inspections, manage quarantine and line clearances, and contribute to continuous improvement initiatives. Requirements: B.S. in life sciences or related field; 2+ years (Assoc QA) or 4+ years (QA Specialist) experience in pharmaceutical quality assurance; proficiency with GMP, GxP, and validation processes. HighValue: support of drug product manufacturing, GMP compliance, cleanroom gowning, and physical demands; location on-site in Rensselaer, NY, with potential for physical tasks up to 10 hours per shift. WorkSetup: 1st shift, Monday–Friday, onsite; physical environment requires gowning and cleanroom procedures.