Quality Assurance Specialist (On the floor)

Responsibilities

• Oversee programs that support visual inspection, assembly, and packaging operations at the drug product facility
• Ensure facilities, equipment, materials, processes, and procedures comply with good manufacturing practices, good documentation practices, safety, and Regeneron requirements
• Develop, update, review, and approve standard operating procedures, specifications, and other documents supporting drug product operations
• Provide quality oversight and guidance during on-the-floor manufacturing activities
• Execute daily on-the-floor oversight to verify facilities, equipment, materials, and documentation comply with standard operating procedures and safety standards
• Perform material quarantine and segregation and execute line clearance activities
• Perform 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 with written procedures
• Provide quality support for electronic batch record design, review, and approval
• Author, review, and approve quality documents, including standard operating procedures, risk assessments, training materials and records, protocols, and reports
• Support and represent quality assurance during audits and inspections, including direct interactions with regulatory agencies as needed
• Gowning and environment:
• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
• Qualified applicants must be able to pass the following vision tests; Ishihara (colorblindness) and Jaeger (paragraphs of decreasing size) as part of the requirements of this role
• Let's find out if we're a fit:
• Requires B.S in life sciences or related field; may substitute proven experience for education requirement Assoc QA Specialist : 2+ years of experience
• QA Specialist : 4 + years of experience
• Sr. QA Specialist: 6+ years of experience
• Level will be determined based on experience
• Thrive today. Grow tomorrow.
• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)

Benefits

Additional Information

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support visual Inspection, assembly, and packaging operations performed at Regeneron's internal Fill/Finish facility. They will provide floor support during production activities and contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International regulatory body requirements. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: Location: Rensselaer, New York, United States Monday-Friday, 8am-4:30pm Occasional flexibility may be requested for on-call schedule/weekend work

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Regeneron? Share your experience