Quality Assurance Specialist (On the floor)

What You’ll Do Oversee programs supporting visual inspection, assembly, and packaging operations at the drug product facility. Ensure facilities, equipment, materials, processes, and procedures comply with GMP, GDP, safety, and Regeneron requirements. Develop, update, review, and approve SOPs, specifications, and other drug product operation documents. Provide quality oversight and guidance during on-the-floor manufacturing activities. Perform daily on-the-floor oversight to verify compliance with SOPs and safety standards. Perform material quarantine/segregation and execute line clearance. Execute acceptable quality level sampling plan. Review and approve procedures, documents, and records, including batch production records and protocols. Ensure electronic and paper batch records are complete, accurate, and compliant. Support electronic batch record design, review, and approval. Author/review/approve quality documents (SOPs, risk assessments, training materials/records, protocols, reports). Represent QA during audits and inspections, including interactions with regulatory agencies. Gowning And Environment Wear full cleanroom attire (e.g., gown, facemask, hairnet, safety glasses/shoes/booties, latex gloves) including sanitizing agents during gowning (e.g., IPA). Remove jewelry/makeup/nail adornments for cleanroom attire. Pass Ishihara (colorblindness) and Jaeger vision tests. Let’s Find Out If We’re a Fit (Qualifications) Required: B.S. in life sciences or related field; proven experience may substitute. Assoc QA Specialist: 2+ years experience. QA Specialist: 4+ years. Sr. QA Specialist: 6+ years. Benefits (as listed) Student loan paydown and tuition reimbursement. Family care benefits. Relocation assistance. Inclusion/culture and well-being programs. #J-18808-Ljbffr Scorpion Therapeutics