Quality Document Manufacturing Specialist
: Job Details :


Quality Document Manufacturing Specialist

Talent Groups

Job Location : Cambridge,MA, USA

Posted on : 2025-01-13T17:24:38Z

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).

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