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Assoc Compliance Specialist

Regeneron Pharmaceuticals

East Greenbush, NYJob$62–92K/yrSeen 5 days agoSeen in employer's feed 5 days ago

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At a glance

Compensation
$62–92K/yr
Location
East Greenbush, NY
Work Authorization
Not specified

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Job overview

The Associate Compliance Specialist supports the Process Sciences department by overseeing cGMP compliance. The role tracks and reviews quality records, serves as a subject matter expert for quality records and systems, promotes technical writing and quality awareness, and coordinates changes across departments. It also maintains metrics and supports a proactive compliance environment through knowledge transfer and education.

Skills & qualifications

RequiredNice to have

Skills

Quality RecordsQuality SystemsTechnical WritingCommunicationCross-Functional CoordinationKnowledge Transfer

Qualifications

BS/BA in Scientific Discipline or Equivalent0-2+ Years Industry Experience

Benefits

401(k) Match
Medical Insurance
Paid Time Off

Full job description

Summary: Supports the Process Sciences department by providing oversight for all aspects of

cGMP compliance.

Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Execute, monitor, and track progress of Process Sciences owned quality records,

such as Change controls, supplier notifications and CAPAs.

  • Be a SME for quality records and quality systems, ensuring consistency of records.

  • Train and promote technical writing and quality awareness.

  • Maintain and communicate appropriate metrics.

  • Review department owned quality records for compliance and accuracy.

  • Strong communicator to represent Process Sciences at daily & weekly cross functional

meetings.

  • Act as a liaison for coordination of changes between the Process Sciences department

and other departments.

  • Drive proactive compliance environment in the Process Sciences department through

knowledge transfer and education of compliance related items.

Education and Experience:

  • Assoc: BS/BA in scientific discipline or related field with 0-2+ years industry

experience; or equivalent combination of education and experience.

  • Int: BS/BA in scientific discipline or related field with 2+ years industry experience; or

equivalent combination of education and experience.

  • Sr: BS/BA in scientific discipline or related field with 5+ years industry

experience; or equivalent combination of education and experience.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $92,400.00

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