Technical Writer
Job in
Pleasant Prairie, Kenosha County, Wisconsin, 53158, USA
Listed on 2026-08-02
Listing for:
Jobtailor
Full Time
position Listed on 2026-08-02
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Responsibilities
- Writing deviations, action plans, trend reports, and engineer change requests (ECR’s)
- Assisting with the writing and revision of standard operating procedures
- Assisting with audit response development
- Taking direction from the Manager of Compliance regarding any related activities as needed
- Managing multiple deviation investigations simultaneously
- Ensuring investigations comply with cGMP regulations
- Collaborating with process experts and production personnel to solve problems
- Writing and revising SOP’s based upon input from operations or other subject matter experts
- Creating trend reports necessary to meet compliance obligations and KPI’s
- On-site presence before and during inspections to support the operations team
- Bachelor of Science degree recommended
- Requires advanced critical thinking skills and expert writing skills
- At least three years’ experience in a GMP environment writing standard operating procedures and/or deviations/action plans
- Must be familiar with regulatory (FDA) requirements
- Good organizational, communication, and interpersonal skills are required
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