As a Compliance Specialist in the Process Sciences group you will support the department by providing oversight on all aspects of cGMP compliance.
As a Compliance Specialist a typical day might include, but is not limited to, the following:
- Monitor and Track progress of Process Sciences owned quality records, such as deviations, Change controls and CAPAs.
- Be a SME for quality records and quality systems, ensuring consistency of records.
- Train and promote technical writing and quality awareness
- Maintain and communicate appropriate metrics
- Review department owned quality records for compliance and accuracy.
- Strong communicator to represent Process Sciences at daily & weekly cross functional meetings
- Act as a liaison between the Process Sciences department and onsite quality and regulatory groups to define and address all issues of non-compliance.
- Drive proactive compliance environment in the Process Sciences department through knowledge transfer and education of compliance related items.
- Coordinate/perform training for Process Sciences personnel on regulatory and quality topics.
- Coordinate regulatory audit preparation for Process Sciences.
To be considered for this opportunity you should have a BSc in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry.
#IRELIM #JOBIEST #LI-Onsite
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.