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 position supports QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility, offering the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

About the role

Location: East Greenbush, New York, United States

Schedule

• 3rd shift, Friday-Tuesday, 10pm-8:30am
• 3rd shift, Monday-Friday, 10pm-8:30am

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, including 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

Work Environment

• Gowning: full cleanroom attire (examples may include: 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
• Physical requirements can include but are 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

Requirements

• B.S in life sciences or related field; may substitute proven experience for education requirement
• Associate QA Specialist: 2+ years of experience
• QA Specialist: 4+ years of experience
• 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): $62,355.00 - $110,000.00