Quality Control Senior Associate (Contract) 25098

Company: Vertex
Location: Boston
Posted on: May 3, 2025

Job Description:

Job DescriptionThe Vertex Cell and Gene Therapy (VCGT) Type 1 Diabetes (T1D) Quality Control (QC) team is responsible for the testing of samples and associated workflows within our stem-cell based T1D program. VCGT T1D QC carries out all activities under Good Manufacturing Practices (GMP) guidelines, including the running of tests and reporting of test results. Daily tasks include running assays, peer reviewing, qualifications, and method transfers. Assays include flow cytometry, qPCR (MycoTOOL), ELISA, cell counts, sterility (BACT), gram stain, and endotoxin.The Quality Control Associate role provides a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing and reporting of in-process, release and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.Key Duties and Responsibilities:

• Performs Quality Control (QC) testing of Cell Therapy in-process, release and stability samples. Typical test methods performed include flow cytometry, qPCR (MycoTOOL), ELISA, cell counts, sterility (BACT), gram stain and endotoxin (LAL) testing.
• Performs technical reviews of raw data.
• Records test results and maintains raw data and accurate laboratory records.
• Performs general lab and equipment maintenance duties.
• Performs other duties as assigned.
• Shift: 1st shift; Wed-Sat 7:30am- 6:00pm est.Knowledge and Skills:
  • Performs tasks with strict adherence to cGMP and cGDP principles.
  • Has an understanding of basic laboratory equipment and practices.
  • Is proficient in the use of spreadsheets and word processing software.
  • Is dependable and able to work well within a team.
  • Is interested in learning new things. Open to change.
  • Is optimistic and displays a positive attitude even during periods of adversity.
  • Shows initiative; acts independently with management approval.
  • Possesses a high attention to detail.Education and Experience:
    • A minimum of a Bachelor's Degree in science (Biology) or related discipline is required.
    • Typically requires 3+ years of experience.Pay Range40-45/hr
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Keywords: Vertex, Concord , Quality Control Senior Associate (Contract) 25098, Other , Boston, New Hampshire