Quality Control Specialist - Cell Therapy

Vertex PharmaceuticalsBoston, MA
437d

About The Position

The Quality Control Specialist in the Vertex Cell and Gene Therapy (VCGT) Type 1 Diabetes (T1D) team is responsible for supporting various analytical functions within the Quality Control (QC) department. This role involves testing samples and ensuring compliance with Good Manufacturing Practices (GMP) while fostering the company's vision and values. The specialist will perform a range of testing methods and maintain accurate laboratory records, contributing to the validation, testing, and reporting of in-process, release, and stability samples.

Requirements

  • A minimum of a Bachelor's degree in sciences is required.
  • 1-3 years of experience in the GMP pharmaceutical/biopharmaceutical industry.
  • Proficiency in the use of spreadsheets and word processing software.
  • Ability to perform tasks with strict adherence to cGMP and cGDP principles.
  • Understanding of basic laboratory equipment and practices.

Nice To Haves

  • Dependable and able to work well within a team.
  • Interest in learning new things and openness to change.
  • Possesses a high attention to detail.
  • Shows initiative and acts independently with management approval.

Responsibilities

  • Perform typical test methods including flow cytometry, qPCR, ELISA, cell counts, sterility testing, Gram stain, and endotoxin testing.
  • Conduct technical reviews of raw data and record test results accurately.
  • Maintain raw data and laboratory records in compliance with GMP guidelines.
  • Perform general lab and equipment maintenance duties.
  • Assist with other assigned duties as needed.

Benefits

  • Equal employment opportunity and non-discrimination policies.
  • Reasonable accommodations for qualified individuals with known disabilities.
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