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Technical Writer

Indianapolis $63,000-$73,000 Contract

Essential Functions:

  • Develop validation protocols and documentation: Craft and author comprehensive validation protocols, test scripts, detailed reports, and user manuals specifically for spreadsheets utilized in regulated industries.
  • Design and update templates for spreadsheet validation to ensure consistency and efficiency.
  • Examine and refine documents to guarantee accuracy, completeness, and uniformity.
  • Monitor the status of documents, manage revisions, and ensure timely updates.
  • Identify and implement opportunities to enhance spreadsheet validation processes and documentation practices.
  • Organize and prioritize projects effectively, ensuring a structured and systematic approach.
  • Uphold operational compliance with US and international regulatory agencies and guidelines, including FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, and cGMP.

Requirements:

  • Bachelor of Science in Chemistry or a related field is essential.
  • Minimum of 3 years of relevant experience in a similar role.
  • Skilled in Microsoft Office Suite or similar software.
  • Excellent time management skills with a proven track record of meeting deadlines.
  • In-depth understanding of, or the ability to quickly grasp, the specifics of the project or product under development.
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