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Manufacturing Technical Writer
Company | Baxter International |
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Location | Johnsburg, IL, USA |
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Salary | $48000 – $66000 |
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Type | Full-Time |
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Degrees | Bachelor’s |
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Experience Level | Mid Level |
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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.