Quality Document Manufacturing Specialist
at Talent Groups
in
Cambridge,
Massachusetts
Posted in Other about 9 hours ago.
Type: full-time
Job Description:
- Bachelor's degree in Engineering or Life Sciences.
- Minimum of 5+ years of Pharma manufacturing industry experience.
Strong knowledge of biologics drug substance production, including:
- Cell banking, plasmid production, and gene therapy BDS.
- Cell culture, chromatography, TFF (tangential flow filtration), and aseptic techniques.
Proven experience with
quality systems documentation, including:
- Deviations, change controls, batch records, and technical reports.
- Demonstrated ability to work independently and deliver results with minimal supervision.
- Skilled in managing multiple competing priorities in a dynamic, fast-paced environment.
- Exceptional communication skills, both written and verbal.
- Project management or collaboration with CDMOs (Contract Development and Manufacturing Organizations).