QA Specialist, Drug Product

Responsibilities

• Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
• Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
• Maintain project timelines to support the evolving business
• Perform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents
• Review and approval of documents (electronic and paper-based)
• Provide mentorship during on-the-floor manufacturing
• Support audits, inspections and investigations
• Perform quarantine, segregation of material and line clearances
• Contribute to the continuous improvement initiatives
• Adjust schedule based on facility start up, filling, and manufacturing needs
• Collaborate with cross-functional internal teams
• The environment and physical rhythms of this role:
• Gowning: 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
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs
• 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
• 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)
• Please be

Benefits

Additional Information

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. When & where: 1st shift, Monday-Friday, 8am-4:30pm Location: Rensselaer, New York, United States

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