Senior Quality Assurance Specialist, On the floor (Overnights)

Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases. Join our QA Drug Product team as a Senior Quality Assurance (QA) Specialist and contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

About the role

This position supports QA initiatives for the start-up and operations of a drug product facility, including formulation, filling, inspection, assembly, and pack and label teams.

Responsibilities

• Lead or contribute to efforts establishing new programs for drug product operations start-up.
• Assess existing procedures/documents for suitability in drug product operations; identify and implement improvements where needed.
• Develop, write, review, and approve SOPs, specifications, and other documents (e.g., operational/facility SOPs, quality training, batch documentation).
• Maintain project timelines to support evolving business needs.
• Perform on-the-floor quality reviews of documents (e.g., equipment logs, training records, testing results, batch records).
• Review and approve electronic and paper-based documents.
• Provide mentorship during on-the-floor manufacturing.
• Support audits, inspections, and investigations.
• Perform quarantine, material segregation, 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

• Full cleanroom attire required (e.g., laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes, booties, latex gloves).
• Use of sanitizing agents (e.g., IPA) during gowning process.
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire.
• Physical requirements include bending, climbing, crawling, kneeling, reaching, sitting, squatting, walking, standing, driving, and hand manipulation.
• Ability to lift/push/pull up to 50 lbs and perform physical tasks for the entirety of a shift (up to 10 hours) in a cleanroom environment.

Requirements

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

Schedule

3rd shift, Friday–Tuesday, 10:00 PM–8:30 AM.

Pay

Annual salary range: $78,700.00 – $128,700.00 (for roles in Canada).

Benefits

• Student loan paydown program & tuition reimbursement.
• Family care benefits.
• Relocation assistance.
• Inclusion, culture, and well-being programs (physical & mental health).
• Competitive total rewards package, including:
  • Annual bonuses or other incentive plans.
  • Equity awards.
  • Pension or retirement benefits (e.g., 401(k) company match).
  • Health and wellness programs (e.g., fitness centers).
  • Insurance benefits (e.g., medical, dental, vision, life, and disability).
  • Paid time off.
  • Family support benefits.

Additional benefits may apply based on country and role. For U.S. benefits details, visit Regeneron Total Rewards. For other locations, details will be provided during recruitment.