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Manufacturing Technical Writer

Manufacturing Technical Writer

CompanyBaxter International
LocationJohnsburg, IL, USA
Salary$48000 – $66000
TypeFull-Time
DegreesBachelor’s
Experience LevelMid Level

Requirements

  • BS/BA in science, engineering, or related field.
  • 2-4 years of relevant work experience in a cGMP-related industry or clinical setting.
  • Strong problem-solving and analytical skills.
  • Excellent written/verbal communication and organizational skills.
  • Ability to make independent decisions with minimum oversight.
  • Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools.
  • Experienced user of TrackWise.
  • Working knowledge of FDA Regulations and International Regulatory requirements.
  • Understanding of risk management tools.
  • Available to work during off-shift or weekends as needed.

Responsibilities

  • Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
  • Complete implementation of CAPAs associated with NCR investigations.
  • Maintain a high level of expertise in current regulatory requirements.
  • Serve as a plant resource for compliance and maintain audit-ready status.
  • Provide mentorship and mentorship on DMAIC problem-solving and process improvement projects.
  • Ensure compliance with local procedures, US & International Regulatory, and Baxter corporate quality requirements.

Preferred Qualifications

    No preferred qualifications provided.