QA Specialist, Drug Product

QA Specialist, Drug Product

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.

When & where:

• 1st shift, Monday-Friday, 8am-4:30pm
• Location: Rensselaer, New York, United States

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

• Associate 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)

• Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

• Salary Range (annually)

• $62,355.00 - $110,000.00

• About Us

• Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

• Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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