QC Virology Specialist

7 days ago

East Greenbush, New York, United States BioSpace, Inc. Full time
Job Details

Regeneron is currently seeking a Quality Control (QC) Analyst for our Virology team with a 1st shift, Monday-Friday, 8am-4:30pm schedule. As a leading biotechnology company, Regeneron successfully manufactures and tests products for patient safety. This lab-based position is responsible for sample chain of custody, sample processing, testing, and test data reporting and archiving.

Key Responsibilities:
  • Ensure proper 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.
  • Perform cell culture activities to support virus testing.
  • Serve as SME for an assigned assay.
  • Assist in data trending, data review, and lab maintenance activities (e.g., cleaning).
  • Participate in non-routine projects.
  • Apply knowledge to assist in investigations and support studies and protocols.
Requirements:
  • Enjoy being responsible for collecting, entering data, and generating reports from electronic systems.
  • Can revise and update standard operation procedures.
  • Can display good manufacturing practices and good laboratory practices at all times.
  • Ensure quality and safety of manufactured products.
  • Follow established safety and environmental guidelines and procedures for all work performed.
  • Immediately report safety and environmental incidents, including injuries, illnesses, near misses, and safety suggestions.
  • Foster a positive safety culture.
Shift Requirements:
  • Ability to perform physical requirements for the entirety of the shift (up to 8 hours):
  • Some physical requirements can include but are not limited to: bending, reaching, reaching overhead, sitting, walking, standing, hand manipulation, and ability to lift/push/pull up to 25lbs.
Education and Experience:
  • BS/BA in Life Sciences or related field; or an equivalent combination of education and experience.
  • For various levels, you must have the following:
  • Associate Virology Analyst: 0-12+ months of experience.
  • QC Virology Analyst: 12-18+ months of experience.
  • Sr. QC Virology Analyst I: 4+ years of experience.
Preferred Experience:
  • Experience performing review of testing performed in a GMP lab (or similar) is preferred.
Regeneron Culture:

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.

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