Analyst I, Quality Control (Contract)

Cambridge, MA

Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approach. This is an exciting hands-on role within our Quality Control team.  We seek a Quality Control professional to review raw data associated with QC stability programs for ancillary materials, starting materials and drug products in support of our early and late-phase clinical development to ensure successful clinical and commercial regulatory filings in the EU and US.  You will provide significant contribution to the daily operations of the Quality Control laboratories.

This position requires partnering with a Contract Testing Organizations (CTO) network.  The position requires a strong knowledge of cGMP.

 

 About the position:

  • Contribute to the operation of Stability programs across a multi-product portfolio
  • Collect raw data from test labs, perform cGMP data review, collate and utilize statistical software to trend analytical data associated with product stability testing
  • Collaborate with Quality, internal functional areas, and CTOs to review and approve documentation, including deviations, CAPAs and OOS/OOT investigation reports

 

About you: 

  • Associate’s or Bachelor’s degree in a scientific discipline, 1-2 years of related experience in a QC GMP environment
  • Familiarity with analytical methods and raw data
  • Experience in word, share point and statistical software packages such as JMP a plus
  • Good attention to detail, work well independently
  • Strong interpersonal skills, highly collaborative team player, with excellent organizational skills, ability to navigate and be successful in fast-paced and highly-matrixed work environment with changing priorities
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
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bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

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