Quality Assurance Specialist, On the floor (Overnights)
Regeneron
Quality Assurance (QA) Specialist
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.
Location: East Greenbush, New York, United States
Work model, available shifts:
- 3rd shift, Friday-Tuesday, 10pm-8:30am
- 3rd shift, Monday-Friday, 10pm-8:30am
What You'll Do:
- 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)
Vacancy posted 4 days ago
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