Compliance Specialist Job In Munster

**Compliance Specialist Role** Support laboratory operations by ensuring adherence to site policies and procedures, maintaining accurate records, and driving compliance-related process improvements.

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.

**Key Responsibilities:** • Ensure oversight and support for PS laboratory operations comply with site data integrity policies and procedures. • Participate in ATRAs, audit trails reviews, data recording, storage, and verification. • Maintain laboratory records in accordance with site procedures, including paper and electronic lab notebooks, laboratory logbooks, equipment maintenance records, and laboratory study protocols and reports. • Complete quality records such as deviations, CAPAs, and change controls with support and oversight provided to PS laboratory personnel. • Purchase, implement, operate, and maintain PS laboratory equipment in accordance with department and site procedures. • Execute, record, and report PS laboratory studies in alignment with department and site procedures. • Drive compliance-related process improvements and efficiencies associated with PS laboratory operations. • Support PS laboratory personnel on compliance-related topics in a supportive and collaborative manner. • Communicate effectively, with strong written and oral skills.

**Requirements:** • Bachelor's degree in Biotechnology, Biochemistry, or a related field. • 2 years of experience in a GMP compliance role. • Strong communication skills. • Ability to maintain accurate records. • Collaborative team player.

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.