Quality Assurance Specialist, Batch Record Review

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron is recruiting a Quality Assurance Specialist to support Batch Record Review activities in Manufacturing. The role ensures QA compliance with cGMPs, SOPs and Regeneron standards, contributing to fast-growing, science-driven work impacting patients worldwide.

The position involves on-site work in Rensselaer, NY with structured 2nd shift hours. You will review batch records, mentor teammates, and drive continuous improvement while collaborating across sites and functions.

Qualifications

• BS/BA in scientific discipline or related field. May substitute proven experience for education.
• Assoc QA Specialist: 0 to 2 years relevant experience.
• Specialist: minimum of 2 years relevant experience.
• Sr Specialist: minimum 6 years relevant experience.

Responsibilities

• Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including investigation, evaluation, and problem resolution.
• Review of completed batch records and collaboration with other departments to resolve issues, communicating with internal and external teams.
• Provide consultation or advice in alignment with QA policies.
• Train and/or mentor junior employees, providing insights on processes and procedures.
• Perform activities associated with disposition of products (document review, shipping, etc.).
• Review, edit, or approve Regeneron controlled documents.
• Perform status labeling of product.
• Continually evaluate Regeneron processes and procedures toward continuous improvement.

Skills

QA in Batch Records

Deviations handling

Change Controls

CAPAs

On-the-floor collaboration

Education

BS/BA in scientific discipline

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance Specialist to support our Batch Record Review activities within Manufacturing. In this role, the Quality Assurance Specialist Performs activities in support of dispositioning products while ensuring compliance with Quality Assurance (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: Rensselaer, New York, United States
• Work model: 2nd, Monday-Friday, 12:00 PM - 8:30 PM

Discover your role:

• Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Review of completed batch records and collaborating with other departments to resolve issues, communicating internally (Tarrytown, Raheen, Temple) and externally effectively
• Provide consultation or advice in alignment with QA policies
• Train and/or mentor junior employees, including providing insights and education on processes and procedures;
• Perform activities associated with disposition of products (e.g. document review, shipping, etc.). Activities may be on the production floor or at a desk.
• Review, edit, or approve Regeneron controlled documents
• Perform status labeling of product
• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

This role requires:

• BS/BA in scientific discipline or related field and the following amount of relevant experience for each level. May substitute proven experience for education requirement.

• Assoc QA Specialist: 0 to 2 years relevant experience.
• Specialist: minimum of 2 years relevant experience.
• Sr Specialist: minimum 6 years relevant experience.
• Level is determined based on qualifications relevant to the role.

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 - $128,700.00