Job Description

Technical Writer

Position Summary:

  • Work Schedule: M-F 1st shift
  • 100% on-site

    • The Role:

  • Author, revise, and maintain Master Batch Records, SOPs, protocols, and related technical documents.
  • Ensure documentation complies with cGMP, FDA regulations, and Catalent standards.
  • Collaborate with cross-functional teams (Quality, Operations, Engineering) to gather technical information and ensure accuracy.
  • Assist with document lifecycle, including approval routing, version control, and archiving.
  • Track and complete corrective actions related to documentation deviations and change controls in the TrackWise system.

    • • All other duties as assigned

    The Candidate:

  • High School Diploma/GED with 3+ years of progressive Technical Writing experience OR Bachelor’s degree in Science, Engineering, or related field (preferred).
  • Familiarity with GMP documentation and change control ...

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