Quality Assurance Investigation Specialist

Responsibilities

• Represent quality assurance in support of complex deviations, change controls, corrective and preventive action etc. including active participation in investigation, evaluation, and problem resolution
• Review and approve batch records
• Communicate quality assurance procedures, collaborate closely with internal or external partners and stakeholders and provide input on regulatory communications
• Train and/or mentor junior employees, including providing insights and education on processes and procedures
• Provides consultation or advice in alignment with quality assurance policies
• Perform activities associated with disposition of raw materials and product (e.g. receipt, inspection, document review, shipping, etc.). activities may be on the floor or at a desk
• Review, edit, or approve Regeneron controlled documents
• Review and approve investigations associated with raw materials or product
• Perform status labeling of product
• The environment and physical rhythms of this role:
• Gowning: full cleanroom attire (examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs
• Let's find out if we're a fit:
• Requires B.S in life sciences or related field; may substitute proven experience for education requirement Assoc QA Specialist : 2+ years of experience
• QA Specialist : 4 + years of experience
• Level will be determined based on experience
• Thrive today. Grow tomorrow.
• Student loan pay down program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)
• 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

Benefits

Additional Information

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Quality Assurance (QA) Specialist to conduct investigations. In this role you will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with 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: Monday-Friday, 8am-4:30pm Location: Rensselaer, New York, United States

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