As a Compliance Specialist within QC you will support the QC organisation in meeting compliance targets through laboratory investigation and deviation management. The Compliance Analyst will report quality system metrics to the group and identify improvements that can be made in all quality system inputs.
A typical day might include, but is not limited to, the following:
* Coordinating and managing preparation for regulatory inspections and internal audits, ensuring QC is audit ready at all times
* Acting as the primary QC point of contact during inspections or audits, addressing inquiries and providing documentation as needed
* Organizing and maintaining QC quality records, including Change Controls, CAPAs, and Workflows
* Leading cross-functional teams during Change Control or CAPA events, ensuring alignment on strategies and resolution plans
* Reviewing, editing and revising controlled documents to ensure compliance with written procedures and regulatory standards
* Monitoring open compliance records, such as CAPAs, Change Controls, and Workflows, to ensure timely resolution and closure
* Reporting quality system metrics to QC teams and other relevant departments to track performance and identify improvement areas
* Representing QC in interdepartmental teams and meetings, ensuring QC perspectives and requirements are considered
* Performing other duties assigned by QC management, demonstrating flexibility and a broad understanding of QC functions
This Role Might Be For You If
* You thrive in a multifaceted and fast-paced environment
* You possess excellent verbal and written communication skills
* You enjoy collaboration with cross functional groups
* You successfully build and develop strategic partnerships
* You demonstrate an ability to work within a successful team
To be considered for this opportunity you should have a BS/BA in Life Sciences or equivalent with 2+ years relevant experience, preferably in the pharmaceutical or biotechnology industries.
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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.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.
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