Quality Document Manufacturing Specialist

job
  • Talent Groups
Job Summary
Location
Cambridge ,MA 02140
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
14 Jan 2025
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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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