Technical Writer

Fresenius Kabi USA

Technical Writer responsible for creating compliance documents in healthcare industry. Engaging in audits and collaborating with compliance teams for effective documentation.

Posted 7/7/2026full-timePleasant Prairie • Wisconsin • 🇺🇸 United StatesMid-LevelSenior💰 $70,000 - $80,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits to include medical, prescription drug, dental and vision coverage

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Deviation WritingAction Plan DevelopmentTrend ReportingSOP RevisionAudit Response Development

Soft Skills

Organizational SkillsCommunication SkillsInterpersonal Skills