Technical Writer

Job Summary The Technical Writer for the Marketing Unit Distribution Center is responsible for writing deviations, action plans, trend reports, and engineer change requests (ECRs). The role also assists with the creation and revision of standard operating procedures, audit response development, and other compliance-related activities as directed by the Manager of Compliance. Salary & Benefits Salary Range: $70,000 – $80,000 based on experience. Final pay determinations depend on experience level, education, knowledge, skills, and abilities. 401(k) plan with company contributions Paid vacation, holiday, and personal days Employee assistance program Health benefits – medical, prescription drug, dental, and vision coverage Life insurance and disability coverage Wellness program Hybrid Role: Onsite 3 days per week. Responsibilities Describe problems, identify possible causes, and collect and organize existing data. Compare causes to facts to determine probable root causes and recommend solutions. Manage multiple deviation investigations simultaneously while ensuring regulatory compliance and cGMP adherence. Collaborate with process experts and production personnel to fully understand and resolve problems. Write and revise SOPs based on input from operations or other subject matter experts. Create impact assessments and investigation reports, working within Kabi Track. Assign corrective/preventive actions (CAPAs) as needed to resolve problems. Inform management on the progress of ongoing investigations and provide information to the MRB Material Review Board. Lead the processing of Engineer Change Requests (ECRs) based on site needs. Create trend reports to meet compliance obligations and KPI requirements. Provide on‑site presence before and during inspections to support the operations team. Utilize Word, Excel, eDMS, and other electronic systems to complete tasks. Maintain compliance with company policies, training requirements, cGMPs, and safety standards. Requirements Bachelor of Science degree recommended. Advanced critical thinking skills and expert writing abilities. At least three years of experience in a GMP environment writing standard operating procedures and/or deviations/action plans. Familiarity with regulatory (FDA) requirements. Strong organizational, communication, and interpersonal skills. Applicants must be authorized to work for any employer in the United States. Equal Opportunity/Affirmative Action Employer Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status. #J-18808-Ljbffr