Technical Writer
Fresenius Kabi USA · Pleasant Prairie, WI · 1 wk ago
HybridSupply Chain$70k–$80k/yrFull-time
Responsibilities
- Writing and revising Standard Operating Procedures (SOPs) based upon input from operations or other subject matter experts
- Creating trend reports necessary to meet compliance obligations and Key Performance Indicators (KPIs)
- Processing Engineer Change Requests (ECRs) based upon site needs
- Managing multiple deviation investigations simultaneously
- Writing and revising Action Plans and Trend Reports
- Assisting with audit response development
- Taking the lead on the processing of Engineer Change Requests (ECR’s) based upon site needs
- Maintaining compliance with company policies, training requirements, cGMPs and safety standards
- Supporting the operations team during on-site presence before and during inspections
Requirements
- Bachelor of Science degree recommended
- At least three years’ experience in a GMP environment writing standard operating procedures and/or deviations/action plans
- Familiarity with regulatory (FDA) requirements
- Advanced critical thinking skills and expert writing skills
- Good organizational, communication, and interpersonal skills