QA Specialist, Drug Product
Regeneron Pharmaceuticals•Rensselaer, IN
•$62,355 - $110,000•Onsite
About The Position
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.
Requirements
- 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
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
Benefits
- Student loan paydown program & tuition reimbursement
- Family Care Benefits
- Relocation assistance
- Inclusion, culture and well-being programs (including physical & mental health)
- 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
- family support benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
