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Temp-QC Analyst (Lab Instrumentation)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Rensselaer, New York
Start date
Sep 5, 2022

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Job Details

Summary:  Support the Quality Control (QC) department by maintaining their laboratory instrumentation in an operational, qualified state. This entails ensuring both instrument hardware and software qualifications are completed in a timely manner and keeping them in a qualified state.

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

  • Coordination of lab equipment installation process including procurement approvals
  • Coordination of activities relating to the qualification, calibration, and maintenance of laboratory equipment and related systems
  • Review / approve qualification and validation documents as needed
  • Scheduling and coordinating all preventive maintenance and repair work performed by outside contractors (includes ensuring vendors are in compliance with site requirements prior to performing equipment related services)
  • Ensure qualification, maintenance, and repair activities are communicated to and scheduled with the affected QC functional area and that area management is informed
  • Review of vendor documentation in support of qualification, preventative maintenance, and repair work
  • Ensure the timely submission of work order requests for QC equipment and that scheduled work is completed appropriately
  • Initiate, track, and close work records in BMRAM equipment database as needed
  • Support change control activities impacting QC equipment; provide impact assessments when required
  • Perform investigations of equipment related deviations as needed
  • Participate in Lab Maintenance activities as needed
  • Complies with all pertinent regulatory agency requirements
  • Writes and revises equipment related SOPs as necessary

Education and Experience:

  • HS Diploma and 2 years of relevant experience required, or BA/BS degree in scientific discipline
  • Experience with Blue Mountain Regulatory Asset Manager (BMRAM) software is a plus

Knowledge, skills and abilities:

  • Time management skills and the ability to communicate effectively, both in writing and verbally, are essential

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