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Job Description
Support Compliance Specialist role in Process Sciences laboratory operations, ensuring adherence to site policies and procedures, data integrity, and equipment maintenance.
Within this role, you will support the Process Sciences laboratory operations by ensuring adherence to site policies and procedures associated with good documentation practices, data integrity considerations, equipment and vendor maintenance, and PS study execution, recording, and reporting. As a Compliance Specialist within Process Sciences, a typical day might include: * Ensuring oversight and support for PS laboratory operations comply with site data integrity policies and procedures. * Participating in ATRAs, audit trails reviews, data recording, storage, and verification. * Maintaining laboratory records in accordance with site procedures, including paper and electronic lab notebooks, laboratory logbooks, equipment maintenance records, and laboratory study protocols and reports. * Completing quality records such as deviations, CAPAs, and change controls with support and oversight provided to PS laboratory personnel. * Purchasing, implementing, operating, and maintaining PS laboratory equipment in accordance with department and site procedures. * Executing, recording, and reporting PS laboratory studies in alignment with department and site procedures. * Driving compliance-related process improvements and efficiencies associated with PS laboratory operations. * Supporting PS laboratory personnel on compliance-related topics in a supportive and collaborative manner. * Communicating effectively, with strong written and oral skills. This role requires a BSc in Biotechnology, Biochemistry, or a related field with 2 years of experience. Previous experience in a GMP compliance role is desirable. Regeneron 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.