Compliance Specialist QC

Within this role you will support QC compliance by managing deviations, investigations, change controls, and CAPAs. Coordinate cross-functional activities, track and report quality system metrics, and drive continuous improvement to meet cGMP and regulatory expectations.

• Authoring and peer-reviewing QC laboratory investigations and deviations, including NOE, EOE, DNF, and GLIF investigations
• Leading and documenting corrective and preventive actions (CAPAs) and change controls
• Coordinating cross-functional teams during change control/CAPA events and deviations and align on action plans
• Reviewing, editing, and revising controlled documents (e.g., SOPs, logbooks) to ensure cGMP compliance
• Creating and maintaining QC quality records and workflows; ensure timely, accurate documentation
• Tracking and maintaining status of open QC compliance records (deviations, CAPAs, change controls, workflows)
• Compiling and reporting quality system metrics to QC leadership and stakeholders
• Conducting cross-functional laboratory investigations across QC; coordinate resources from multiple departments
• Representing QC in interdepartmental meetings and cross-functional forums
• Driving continuous improvement in laboratory investigation practices and quality system processes
• Supporting and participating in regulatory inspections
• Performing other tasks as assigned by the Manager

This role may be for you if you:

• Train and mentor compliance team members
• Take increased ownership for authoring, reviewing, and approving documents and data
• Represent Compliance in cross-functional site meetings
• Perform advanced technical writing (SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations)

To be considered for this opportunity you should have a BS/BA in Life Sciences or equivalent, preferably with experience in pharmaceutical or biotechnology industries.

Education & Experience:

• Associate Compliance Specialist (QC): 0-2 years of relevant experience
• Compliance Specialist (QC): 2 years of relevant experience
   

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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 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.