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QC Tech Writer

2 months ago

Waltham, United States Ehub Global Inc Full time

Title: QC Tech Writer

Location: Waltham, MA onsite at least 2x per week

Duration: 6m+


Schedule: M-F 9-5pm


The Role:

This position will work with Quality management to author and review documents in support of programs as well as routine QC operations. The primary focus will be tracking, writing, and reviewing quality events.


Here’s What You’ll Do:

  • Draft and review quality events, including deviations, lab investigations, and CAPAs.
  • Draft, edit, and/or review SOPs, as needed, to close out quality events.
  • Track open quality events and work with SMEs/management to ensure on-time closure.


Requirements:

  • B.S. or M.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3 years of experience in GMP QC laboratory setting, preferably in a cell and gene therapy manufacturing environment.
  • Experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, cell-based assays, sterility, environmental monitoring) is preferred.
  • Strong knowledge of GMPs, SOPs, and Quality system processes.