Quality Assurance Specialist (On the floor)
Regeneron
June 29, 2026
On-site
East Greenbush, NY
Operations
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.
Application
- Apply now.
- 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.
Application
- Apply now.