Technical Writer

Fresenius Kabi • Pleasant Prairie, WI

9d • Hybrid

About The Position

The Technical Writer is responsible for the writing of deviations, action plans, trend reports, and engineer change requests (ECR’s) for the Marketing Unit Distribution Center. Additionally, the role will assist with the writing and revision of standard operating procedures, assist with audit response development, and take direction from the Manager of Compliance regarding any related activities as needed. Salary Range: $70,000 - $80,000 based on experience. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Hybrid role: Onsite 3 days per week. Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Requirements

• 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

Nice To Haves

• Bachelor of Science degree recommended

Responsibilities

• Describing problems, identifying possible causes, collecting, understanding, and organizing existing data, comparing causes to facts, identifying probable root causes, and helping to determine the best solutions
• Managing multiple deviation investigations simultaneously
• Ensuring investigations will withstand regulatory scrutiny and are compliant with cGMP regulations
• Working with process experts and production personnel to fully understand and solve problems, providing technical expertise and recommending improvements
• Writing and revising SOP’s based upon input from operations or other subject matter experts
• Writing Impact Assessments and Investigation Reports, working within Kabi Track
• Assigning corrective/preventive actions (CAPAs) as necessary in order to resolve problems
• Informing Management on the progress of on-going investigations, providing information to and taking direction from the MRB Material Review Board
• Taking the lead on the processing of Engineer Change Requests (ECR’s) based upon site needs
• Creating trend reports necessary to meet compliance obligations and KPI’s
• On-site presence before and during inspections to support the operations team
• Utilizing Word, Excel, eDMS and other electronic systems to complete tasks
• Maintaining compliance with company policies, training requirements, cGMPs and safety standards

Benefits

• 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
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level