Senior Quality Assurance Specialist, On the floor (Overnights)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. This role supports QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility, contributing to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

About the role

Location: East Greenbush, New York, United States
Work model: 3rd shift, Friday–Tuesday, 10:00 PM–8:30 AM

Responsibilities

• Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label teams
• 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 (e.g., operation and facility SOPs, quality training, batch documentation)
• 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 continuous improvement initiatives
• Adjust schedule based on facility start-up, filling, and manufacturing needs
• Collaborate with cross-functional internal teams

Work Environment

• Gowning: full cleanroom attire (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves; use of sanitizing agents such as IPA during gowning process)
• 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 cleanroom environment, including 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 50 lbs

Requirements

• B.S. in life sciences or related field and 6+ years of experience; may substitute proven experience for education requirement
• Level will be determined based on experience

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture, and well-being programs (including physical & mental health)
• Competitive and comprehensive total rewards package, which may include (depending on country and role): annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g., medical, dental, vision, life, and disability), paid time off, and family support benefits

Pay

Salary Range (annually): $78,700.00 – $128,700.00