.. the acceptability of results against predetermined criteria Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements Reviewing, editing and approving deviation notifications, deviation investigations, and corrective actions Reviewing .. read more
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 is essential. Types of records include 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 is a responsibility 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 is a key task Supporting PS laboratory personnel on compliance-related topics in a supportive and collaborative manner is important Communicating effectively, with strong written and oral skills, is crucial 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 Biotechnology, Biochemistry or related field with 2 years' experience will be considered. Previous experience in a GMP compliance role desirable. #JOBSIEST 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. The Company 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. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.