QA Specialist, Internal Bulk Batch Review
About The Position
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.
Requirements
- 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.
- 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
Responsibilities
- 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
Benefits
- 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
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
