Qa Specialist (Batch Record Review)

• Participate as a QA representative on Technology Transfer Startup Teams where responsibilities include providing guidance on QA procedures and polices as well as review of documents for both internal and external transfers
• Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
• Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Performing status labeling of product
• Providing consultation or advice in alignment with QA policies
• Performing activities associated with disposition of product (e.g. document review, shipping), activities may be on the floor or at a desk
• Reviewing, editing, or approving Regeneron controlled documents
• Reviewing completed records and batch sheets and working with other departments and communicate internally (Tarrytown, Raheen) and externally effectively

This role may be for you if you:

• Can prioritize multiple assignments and changing priorities
• Excel in a quality driven organization
• Are able to learn and utilize computerized systems for daily performance of tasks
• Have an understanding of biologics manufacturing operations
• Are organized and have an attention to detail

To be considered for this role you must hold a Bachelor’s degree and the following amount of relevant experience for each level:

• QA Associate – 0-2+ years
• Associate QA Specialist – 2+ years
• Sr QA Specialist – 6+ years
• QA Specialist – 4+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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