About the role

  • Quality Control Analyst responsible for routine testing of samples in a cGMP lab. Focused on supporting advanced cell therapies at Vericel Corporation.

Responsibilities

  • Perform routine QC testing for raw materials, in-process, DP, and stability samples.
  • Use equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, plate reader, etc.
  • Perform cell culture microbial and/or molecular assays.
  • Conduct routine Environmental Monitoring and utilities testing.
  • Perform microbial limits, Bioburden testing, and identifying and trending microorganisms.
  • Provide lab support including but not limited to glass washing and autoclaving.
  • Assist in the review of QC data and provide summaries to management.
  • Report out-of-specification or out-of-trend results.
  • Perform QC general laboratory equipment calibration and maintenance.
  • Maintain laboratory housekeeping and preparation for audits.
  • Participate in transfer methods from support groups to the QC laboratory.
  • Coordinate departmental systems including inventory and documentation.
  • Communicate inter-departmentally for technical issues.
  • Author and conduct periodic reviews to QC documents.

Requirements

  • BS plus 0-2 years’ industry experience in cGMP lab environment, or AS, 2-4 years’ industry experience.
  • HS Diploma, 4+ years’ industry experience in cGMP lab environment, or equivalent.
  • Basic working knowledge of cGMP regulations and/or lab experience
  • 1 year of experience in a cGMP lab environment.
  • Proficient in Outlook, MS Word, Excel and lab based data management systems (LIMs).
  • Experience with microbiological testing or environmental monitoring.
  • Experience in biotech, pharmaceutical or other regulated industry.

Benefits

  • Competitive salary
  • Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation

Job title

Quality Control Analyst, I

Job type

Experience level

Mid levelSenior

Salary

$32 - $38 per hour

Degree requirement

Bachelor's Degree

Location requirements

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