Quality Assurance Specialist (Batch Record & Disposition)

Regeneron; New York (NY); On-site; USD 62,000 - 110,000; Full time

Job summary

Regeneron seeks a Quality Assurance Specialist for the batch record and disposition team in East Greenbush, NY. The role ensures product disposition per QA policies, cGMPs, and SOPs, with responsibilities spanning investigations, document reviews, and external collaboration.

Ideal candidates have 4+ years of QA experience in life sciences. On-site role with some domestic travel and a typical 8am–4:30pm schedule, with salary range disclosed.

Qualifications

• 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.

Responsibilities

• Represent QA in support of deviations, change controls, CAPAs, and investigations.
• Represent QA with external partners to communicate QA policy and procedures.
• Provide consultation in alignment with QA policies.
• Dispostion of product, including document review and disposition packs.
• Review, edit, or approve Regeneron controlled documents.
• Review investigations related to raw materials, product, labs, facilities.
• Contribute to continuous improvement of Regeneron processes and procedures.
• May train or mentor junior employees on QA processes.

Skills

QA

CAPA

Deviation investigation

Documentation review

Education

B.S in life sciences or related field

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We're seeking a Quality Assurance (QA) Specialist to join our batch record & disposition team. This role performs and leads activities in support of dispositioning product while ensuring compliance with QA policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: East Greenbush, New York, United States

Work model: Monday-Friday, 8am-4:30pm

Travel percentage: 10% domestic

Discover your role:

• Represent QA in support of complex and/or significant deviations, change controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Represent the IOPS (Industrial Operations Product Supply) organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on issues occurring at external sites
• Provides consultation or advice in alignment with QA policies
• Performs activities associated with disposition of product (e.g. document review, disposition pack preparation, Certificate of Analysis Review)
• Reviews, edits, or approves Regeneron controlled documents
• Reviews and approves investigations associated with raw materials, product, laboratory, facilities, or materials
• Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement
• May train and/or mentor junior employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization

This role 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

#REGNQA

Does this sound like you? 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.

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.

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)
$62,355.00 - $110,000.00