QA Specialist, Internal Bulk Batch Review
Regeneron Pharmaceuticals
Summary
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.
Job description
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.
Requirements
- BS/BA in scientific discipline or related field
- Minimum of 2 years relevant experience for Assoc QA Specialist
- Minimum of 4 years relevant experience for Specialist
- Minimum of 6 years relevant experience for Sr Specialist
- Understanding of biologics manufacturing operations
- Experience in a quality driven organization
- Strong organizational skills and attention to detail
- Good written, verbal and interpersonal communication skills
- Ability to effectively interact cross functionally
- Ability to manage multiple assignments and changing priorities
- Ability to learn and utilize computerized systems
- Ability to prioritize, manage multiple tasks, and meet deadlines
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.