QC Specialist I – Technical Writer
| Company | ElevateBio |
|---|---|
| Location | Waltham, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Mid Level |
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.
- Strong knowledge of GMPs, SOPs, and Quality system processes.
- Proficient at writing concise and thorough deviations and lab investigations.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent organizational skills.
- Experience performing laboratory investigations.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP).
Responsibilities
- Draft and review quality events, including deviations, lab investigations, change controls, and CAPAs.
- Draft, edit, and/or review procedures, as needed, to close out quality events.
- Track open quality events and work with SMEs/management to ensure on-time closure.
- Assist with data review, tracking, and trending.
Preferred Qualifications
- Experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, cell-based assays, sterility, environmental monitoring) is preferred.