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We are currently looking to fill a Compliance Specialist (Quality Control) position. This position will support the QC Analytical Sciences organization as the point person for GMP compliance, data integrity, investigations, and workflow management.

In this role, a typical day might include the following:

• Department Subject Matter Authority on quality systems and compliance standards.

• Investigate non-conformances (deviations, laboratory OOS/OOT results).

• Analyze and evaluate information collected through investigations and summarize findings in investigation reports.

• Strive for continuous improvement in investigation practices to cultivate compliance and meet regulatory expectations.

• Handle workflows and change controls associated with departmental procedural updates.

• Assist with lifecycle management for SOPs including periodic reviews and ensuring compliance and consistency across documents.

• Participate in and/or lead cross functional team discussions about investigations and procedural updates.

• Represent the team on interdepartmental teams and in meetings.

• Interact with senior internal personnel on significant matters often requiring coordination between functions.

• Serve as a resource on the compliance system and provides direction to laboratory analysts with respect to compliance and documentation requirements.

• Produce and maintain accurate records.

• Administers effective, accurate, and timely communication.

• Assist in performing laboratory inspections for GMP compliance, suggest and implement corrective actions to keep the laboratory in inspection ready state.

This role may be for you if you have:

• Excellent written and verbal communication skills

• Strong interpersonal skills and attention to detail

• Ability to prioritize, re-prioritize as needed and adapt to change

• Proficient skills in Excel, PowerPoint, Project, Word, etc.

• Resiliency and flexibility in the face of challenges and adversarial situations

To be considered for this role you must hold a Bachelors degree in Life Sciences, Engineering or related field and the following amount of relevant experience for each level:

• Associate Compliance Specialist – 0-2+ years

• Compliance Specialist – 2+ years

• Sr Compliance Specialist – 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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.

Salary Range (annually)

$58,480.40 - $124,300.00