Regeneron Pharmaceuticals Quality Assurance Specialist
3 weeks ago
Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Regeneron Pharmaceuticals.
Key Responsibilities:
- Perform activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
- Work closely with Clinical Pack and Label Contract Manufacturing Organizations.
- Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc.
- Review and approval of investigations associated with product, laboratory, facilities, and materials.
- Train and/or mentor junior employees, including providing insights and education on processes and procedures.
- Provide consultation or advice in alignment with QA policies.
- Perform activities associated with disposition of raw materials and product (e.g., receipt, inspection, document review, shipping, etc.).
- Review, edit, or approve Regeneron controlled documents.
- Perform status labeling of raw materials and product.
- Understanding of biologics manufacturing operations and packaging operations is helpful.
- Ability to learn and use computerized systems for daily performance of tasks.
- Ability to work a varied schedule including off shift and weekends.
Requirements:
- Bachelor's degree.
- 4+ years of relevant experience for QA Specialist.
About Regeneron Pharmaceuticals:
Regeneron Pharmaceuticals 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
Regeneron Pharmaceuticals will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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