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Technical Writer

Fresenius Kabi -
Pleasant Prairie, WI

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Job Details

Full-time
$70,000 - $80,000 a year
8 days ago

Benefits

Wellness program
Paid holidays
Health insurance
Dental insurance
401(k)
Employee assistance program
Vision insurance
Life insurance

Qualifications

Pharmaceutical regulatory compliance
Technical writing experience within manufacturing
Biomedical regulatory compliance
FDA regulations

Full Job Description

Job Summary

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.

Responsibilities

The Technical Writer is responsible for 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

Responsible for managing multiple deviation investigations simultaneously

Ensures investigations will withstand regulatory scrutiny and are compliant with cGMP regulations

Works with process experts and production personnel to fully understand and solve problems, provides technical expertise and recommends improvements

Writes and revises SOP’s based upon input from operations or other subject matter experts

Writes Impact Assessments and Investigation Reports, works within Kabi Track

Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems

Informs Management on the progress of on-going investigations, provides information to and takes direction from the MRB Material Review Board

Takes the lead on the processing of Engineer Change Requests (ECR’s) based upon site needs

Creates trend reports necessary to meet compliance obligations and KPI’s

On-site presence before and during inspections to support the operations team

Utilizes Word, Excel, eDMS and other electronic systems to complete tasks

Maintains compliance with company policies, training requirements, cGMPs and safety standards

Requirements:

· 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

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.

Work Location: Hybrid remote in Pleasant Prairie, WI 53158

Quick Apply

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