Sr. QA Specialist, Internal Bulk Batch Review

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron is seeking a Sr. Quality Assurance Specialist to support Internal Bulk Batch Review activities within Manufacturing. The role ensures dispositioning of products in compliance with QA policies, cGMPs, SOPs, and Regeneron standards.

Location is Rensselaer, NY with a Monday–Friday schedule. The ideal candidate has a BS/BA in a scientific discipline and at least 6 years of QA experience, including experience with Deviations, Change Controls, and CAPAs.

Qualifications

• BS/BA in scientific discipline or related field.
• Minimum 6 years relevant QA experience.
• Experience with Deviations, Change Controls and CAPAs.

Responsibilities

• Represent QA in deviations, change controls, CAPAs and investigations.
• Review batch records and coordinate with other departments to resolve issues.
• Provide QA consultation and guidance in line with QA policies.
• Train or mentor junior staff on processes and procedures.
• Disposition of products and related documentation.
• Review, edit or approve Regeneron controlled documents.
• Status labeling of product and strive for continuous process improvement.

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 Sr. 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.
• 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.

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.

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.

Salary Range (annually) $92,200.00 - $150,600.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

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.

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

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.