QA Specialist, Internal Bulk Batch Review

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Quality Assurance Specialist to support Internal Bulk Batch Review activities in Manufacturing. You will participate in deviations, change controls and CAPAs, review batch records, and collaborate across departments to resolve issues while ensuring QA policy compliance.

The role requires a BS/BA in a scientific field, with 2–6 years of QA experience depending on level.

Qualifications

• BS/BA in scientific discipline or related field; substitution of experience allowed.
• Minimum experience: Assoc QA Specialist: 2+ years; Specialist: 4+ years; Sr Specialist: 6+ years.
• Understanding of biologics manufacturing operations and QA processes.
• Ability to prioritize tasks and meet deadlines in a fast-paced environment.

Responsibilities

• Represent QA in deviations, change controls, CAPAs and investigations.
• Review batch records and coordinate with departments to resolve issues.
• Provide QA guidance aligned with policies and procedures.
• Train/mentor junior staff and support process education.
• Dispostion activities including document review and labeling.

Skills

Deviations review & investigation

Change controls

CAPA handling

Cross-functional communication

Documentation & QA policies

Education

BS/BA in scientific discipline

Tools

Computerized systems

Batch record review tools

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 Internal Bulk Batch 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: 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 might be for you if:

• Have an understanding of biologics manufacturing operations
• Excel in a quality driven organization
• Are organized and have an attention to detail.
• Have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Can manage multiple assignments and changing priorities.
• Can learn and utilize computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines

This role requires:

Requires BS/BA in scientific discipline or related field and minimum. May substitute proven experience for education requirement.

• Assoc QA Specialist: minimum of 2 years relevant experience.
• Specialist: minimum of 4 years relevant experience.
• Sr Specialist: minimum 6 years relevant experience.

Level is determined based on qualifications relevant to the role.

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. 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)

$92,200.00 - $150,600.00