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Technical Writer

4 months ago


Fremont, United States Fladger Associates Full time

Responsibilities:

  • Excellent employment opportunity for a Technical Writer in the Fremont, CA area.
  • May be responsible for coordinating the display of graphics and the production of the document.
  • Writes a variety of technical articles, reports, brochures, and/or manuals for documentation for a wide range of uses.
  • Paper batch record authoring/revision/template creation CAPA execution/follow-up for doc revisions SOP revisions/authoring Update/create training documents w/ training specialist.


Experience:

  • Bachelor’s Degree Technical writing certification preferred.
  • Minimum 2 years relevant experience in the Pharmaceutical, Biotech, Medical Device, or other regulated environment
  • Familiar with a variety of the field’s concepts, practices, and procedures.
  • Strong technical writing skills
  • Experience authoring and revising cGMP documentation for commercial operations.
  • Advanced proficiency in MS Word
  • Working knowledge of cGMP document control systems Intermediate knowledge of biopharmaceutical operations preferred
  • Required Skills: CONTROL SYSTEMS, DOCUMENT CONTROL, CGMP, OPERATIONS, BIOPHARMACEUTICAL
  • Additional Skills: MEDICAL DEVICE, WRITING SKILLS, SOP, DOCUMENTATION, BATCH RECORD, CORRECTIVE AND PREVENTIVE ACTION, MICROSOFT WORD