Quality Assurance Specialist, On the floor (Overnights)

Role: QA Specialist supporting drug product manufacturing at Regeneron's East Greenbush facility, focusing on quality assurance during startup and operations. Responsibilities include developing and reviewing SOPs and batch documentation, conducting on-the-floor quality reviews, supporting audits and investigations, and ensuring compliance with GxP standards in a cleanroom environment. The role involves collaboration with cross-functional teams during facility startup, filling, and manufacturing. Requirements: B.S. in life sciences or related field; 2+ years (Assoc QA Specialist) or 4+ years (QA Specialist) of relevant QA experience; knowledge of GMP regulations; ability to perform physical tasks in a cleanroom setting; flexibility for shift work. Preferred: experience supporting drug manufacturing startups, expertise in documentation, and quality systems. HighValue: biologics or small molecule drug production, GMP, cleanroom environment, quality assurance, facility startup, regulatory compliance, and cross-functional collaboration. WorkSetup: on-site in East Greenbush, NY, with shift options.