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Quality Compliance Specialist - Product Compliance Operations

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Apr 28, 2022

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Job Details

The Quality Compliance Specialist - Product Compliance Operations maintains site compliance of operations of Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. This person will become involved to meet schedules or resolve problems.

They day to day of a Quality Compliance Specialist for Complaint Operations could include:

  • Actively participate in continuous improvement initiatives.
  • Interprets compliance requirements for incorporation into company systems/procedures.
  • Identify gaps in systems and develop feasible plans for correction
  • Assist with compiling information and requests in support of regulatory inspections and partner audit operations. Includes determining the content required to fill those requests.
  • Maintain team documents and records ensuring content is accurate and up to date supporting inspection readiness
  • Reconciliation of records with outside vendors and outside IOPs Regeneron departments
  • Maintain communication and relationship with outside vendors and Regeneron departments
  • Review, edit, or approve Regeneron controlled documents such as SOPs, Change Controls and deviations

To be considered for the role, you must have a BS/BA in scientific subject area or related field and

  • 1-3 years of relevant work experience in pharmaceutical or related industry desirable for an Associate Quality Compliance Specialist
  • 3-5 years of relevant work experience in pharmaceutical or related industry for a Quality Compliance Specialist
  • 8+ years of relevant work experience in pharmaceutical or related industry for a Senior Quality Compliance Specialist
  • Relevant experience may be considered in lieu of educational requirement.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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