Job Description
Within this role you will support the Process Sciences laboratory operations by supporting adherence to site policies and procedures associated with but not limited to 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, but is not limited to, the following:- 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 might be for you if:
- You contribute to knowledge sharing and process improvement.
- You possess strong communication skills.
- You are diligent in maintaining accurate records.
- You thrive in a collaborative team setting.
To be considered for this opportunity, you should have a BSc in Biotechnology, Biochemistry, or a related field with 2 years of experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels
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.