Associate Compliance Specialist - External Manufacturing

The Associate Compliance Specialist, Drug Product Manufacturing is a member of the Drug Product Manufacturing Team and is responsible for operations support and compliance related activities for the manufacture of Regeneron products.

As an Associate Compliance Specialist, a typical day might include but is not limited to the following:
• Leading and managing CAPAs and change controls
• Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement
• Responsible for generating and tracking performance metrics
• Maintaining knowledge of current good manufacturing practices cGMPs
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures
• Travelling to contract manufacturers or business partners, as required (25% or less)
• Maintaining required training status on Regeneron specific work instructions and SOP’s
• Assisting in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers
• Continuous Process Improvement Implementation
• May require supervisory responsibilities

In order to be considered for this position, you must hold a BS/BA degree in a related scientific field along with

Associate Specialist: 0-2 years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products)

Specialist: 2+ years of related experience in cGMP manufacturing operations (clinical and/or commercial drug products)

May consider equivalent combination of education and experience. Level will be determined based on qualification and experience relevant to the role.

#IRELIM #JOBSIEST #LI-Onsite

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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.S.-based 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.