Technical Writer

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Industry: Technical Writer / Content writer
Job Number:

Description:

  • Manufacturing Senior Technical Writers work cross-functionally with Manufacturing, MS&T, and Quality groups to lead MO deviation investigations, and author/revise GMP documentation to support clinical and commercial lot release for 2 CAR T products. The Senior Technical Writer will also be responsible for working with the MO and QA teams to agree on appropriate CAPAs as needed and ensure on time implementation and closure of actions. The Senior Technical writer will write, revise, and review all related GMP documentation for S12 CAR T manufacturing operations including SOPs, Batch Records, and Work Instructions.

Responsibilities:

  • Lead Manufacturing NOEs and deviation investigations to ensure on time closure
  • Responsible for opening change controls as needed to revise Batch Records, SOPs, Work Instructions to support new product/process implementation, and close CAPAs
  • Participate in cross-functional deviation and CAPA meetings and initiatives in S12
  • Demonstrated ability to collaborate with Manufacturing Operations, QA, MS&T, and other groups to appropriately assign deviation investigations and CAPAs, and support closure
  • Serve as a credible SME as needed during audits to present and defend deviation investigations
  • Identify opportunities to streamline the deviation investigation process for thorough, efficient investigations
  • Other duties may be assigned, as necessary

Skills:

  • Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products
  • Knowledge of cGMP/FDA regulated industry
  • Basic mathematical skills
  • Strong technical and compliance writing capability
  • Proficient in MS Office applications
  • Background to include an understanding of biology, chemistry, medical or clinical practices
  • Previous experience leading and closing deviation investigations to support lot release

Education/experience:

  • Master’s degree plus 2 years of experience in Manufacturing Technical Writing or in a QA role
  • OR Bachelor’s degree plus 5-7 years of experience in Manufacturing Technical Writing or in a QA role
  • OR Associate/ Medical Technical degree and 10 years of Manufacturing or Operations experience
  • OR High School diploma/GED and 15 years of Manufacturing or Operations experience, with emphasis on Technical Writing and/or QA

Additional Job Requirements:      

  • None


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