Associate Quality Control Virology Analyst

Regeneron PharmaceuticalsValley, AL
$22 - $34Onsite

About The Position

Regeneron is looking for an Associate Quality Control Virology Analyst. In this role you will be responsible for sample chain of custody, sample processing, testing and test data reporting and archiving. A typical day in this position may include: · Ensure proper level of laboratory supplies and reagents and maintain laboratory in an audit readiness stage and cGMP compliant manner at all times. · Perform routine and non-routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured in-process commercial and clinical products according to cGMP and associated standard operating procedures. · Review data for conformance to cGMP and specifications and assist with investigation of laboratory deviations. · Collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities. · Apply basic and advanced troubleshooting methods. · Serve as SME for an assigned assay. · Assist in data trending, data review, and lab maintenance activities. · Participate in non-routine projects.

Requirements

  • BS/BA in Cell Biology, Microbiology, Biochemistry, or related Science.
  • Experience working in a GMP virology or cell culture lab is strongly preferred.
  • Can apply knowledge to assist in investigations and support studies and protocols
  • Have experience performing cell culture activities to support virus testing
  • Can be responsible for collecting, entering data and generating reports from electronic systems
  • Always display good manufacturing practices and good laboratory practices.
  • Work well in a fast-paced environment.

Responsibilities

  • Ensure proper level of laboratory supplies and reagents and maintain laboratory in an audit readiness stage and cGMP compliant manner at all times.
  • Perform routine and non-routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured in-process commercial and clinical products according to cGMP and associated standard operating procedures.
  • Review data for conformance to cGMP and specifications and assist with investigation of laboratory deviations.
  • Collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities.
  • Apply basic and advanced troubleshooting methods.
  • Serve as SME for an assigned assay.
  • Assist in data trending, data review, and lab maintenance activities.
  • Participate in non-routine projects.

Benefits

  • 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
  • paid leaves (e.g., military and parental leave)
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