Quality Assurance Specialist (External Filling)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is seeking a Quality Assurance (QA) Specialist to focus on our external filling operations. This position performs activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

When & where:

• Location: East Greenbush, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
• Travel percentage: 5% domestic

What you’ll do:

• Reviews and approves executed batch records from external drug product filling sites
• Reviews and approves master batch records from external drug product filling sites
• Represents Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; liaises with external partners and provides input on regulatory communications
• Trains and/or mentors junior employees, including providing insights and education on processes and procedures
• Provides consultation and advice in alignment with QA policies
• Performs activities associated with disposition of raw materials and product (receipt, inspection, document review, shipping), on the floor or at a desk
• Reviews, edits, or approves Regeneron controlled documents
• Participates in investigations associated with raw materials or product
• Performs status labeling of product
• Continually evaluates Regeneron processes and procedures with an eye toward continuous improvement

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
  • Quality Assurance Specialist: 4+ years of experience
  • Senior Quality Assurance 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)

#REGNQA

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)