Quality Assurance Specialist (On the floor)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support visual Inspection, assembly, and packaging operations performed at Regeneron’s internal Fill/Finish facility. They will provide floor support during production activities and contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International regulatory body requirements. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Rensselaer, New York, United States
• Monday-Friday, 8am-4:30pm
• Occasional flexibility may be requested for on-call schedule/weekend work

What you’ll do:

• Oversee programs that support visual inspection, assembly, and packaging operations at the drug product facility
• Ensure facilities, equipment, materials, processes, and procedures comply with good manufacturing practices, good documentation practices, safety, and Regeneron requirements
• Develop, update, review, and approve standard operating procedures, specifications, and other documents supporting drug product operations
• Provide quality oversight and guidance during on-the-floor manufacturing activities
• Execute daily on-the-floor oversight to verify facilities, equipment, materials, and documentation comply with standard operating procedures and safety standards
• Perform material quarantine and segregation and execute line clearance activities
• Perform acceptable quality level sampling plan
• Review and approve procedures, documents, and records, including batch production records and protocols
• Ensure electronic and paper batch records are complete, accurate, and compliant with written procedures
• Provide quality support for electronic batch record design, review, and approval
• Author, review, and approve quality documents, including standard operating procedures, risk assessments, training materials and records, protocols, and reports
• Support and represent quality assurance during audits and inspections, including direct interactions with regulatory agencies as needed

Gowning and environment:

• 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
• Qualified applicants must be able to pass the following vision tests; Ishihara (colorblindness) and Jaeger (paragraphs of decreasing size) as part of the requirements of this role

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
  • Sr. QA Specialist: 6+ 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)