Job Description
The Associate Compliance Specialist-External Manufacturing is a member of the External Manufacturing Team and is responsible for operations support and compliance related activities for the manufacture of Regeneron products. This is a temporary 12-month contract position. A typical day might include, but is not limited to, the following: Leading and managing deviation investigations, CAPAs and change controls Reviewing and maintaining procedures, polices and other instructional documents with a focus on continuous improvement Generating and tracking performance metrics Maintaining good knowledge of current good manufacturing practices (cGMPs) Completing periodic reviews of External Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures Traveling to contract manufacturers or business partners, as the need arises (25% or less) Maintaining training status on Regeneron specific work instructions and SOPs Assisting in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at External Manufacturing contract manufacturers Implementing continuous process improvements May require supervisory responsibilities This role might be for you if: You have a solid understanding of External Manufacturing from formulation through the final package You have an understanding of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations You are proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments You exhibit confidence and have strong interpersonal, written and oral communication skills for providing team updates You can show resilience and flexibility in the face of challenges and adversarial situations You have experience in collaborating with CMOs/CROs To be considered for this position you must hold a BS/BA in a scientific discipline and 0-2 years' experience is required. #REGNIEEC 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.