Technical Writer
Fresenius Kabi —Pleasant Prairie, WI
- $70,000 - $80,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Background check
- Bachelor of Science
- Wellness program
- Paid holidays
Quick Apply
8d
Clinical Medical Writer Consultant
Kaztronix —San Diego, CA
- Contract
- Remote
- 8 years
- Bachelor's degree
- Continuous improvement
Quick Apply
6d
Creative Writer – Weekly Blogging Program (Contract)
The Exceptional Plan —Remote
- $27.00 - $32.52 an hour
- Contract
- Remote
- Entry level
- Flexible schedule
Quick Apply
7d
Writer
TrueShort —California
- Full-time
- Hybrid work
- Research
- Mid-level
- Leadership
Quick Apply
Proofreader
MISSION PRE-BORN INC —Remote
- $25 an hour
- Full-time
- Remote
- Google Workspace
- English
- Mid-level
8d
Fantasy Football Writer/Content Creator
FlurrySports —Remote
- $10 - $1,000 a month
- Choose your own hours
- Remote
- Fair chance
- Internship
- Communication skills
Quick Apply
Contract Writer - The Western Journal - News
Liftable Media —Remote
- $15 - $20 an hour
- Part-time
- Background check
- Research
- Mid-level
Contract Writer - The Western Journal - Opinion/Commentary
Liftable Media —Remote
- $15 - $20 an hour
- Choose your own hours
- Remote
- Background check
- Research
- Organizational skills
Academic Book Indexer (Humanities & Social Sciences)
Flatpage —Remote
- Contract
- Mid-level
- 3 years
- Analysis skills
Senior Writer
Hasbro Inc. —Austin, TX
- $109,100 - $163,700 a year
- Mid-level
- 4 years
- Communication skills
- Paid parental leave
- Paid holidays
Proposal Writer
World Learning —Myrtle Point, OR
- Contract
- Remote
- 7 years
- Master's degree
- Senior level
Quick Apply
13d
Writer/Digital Content Creator
Fragomen —Remote
- Full-time
- Background check
- Research
- Mid-level
6d
Content Writer
AS BPO Solutions —Lewes, DE
- Research
- Entry level
Communications Analyst (Contract)
Blue Star Partners LLC —Remote
- $55 - $60 an hour
- Contract
- Remote
- 5 years
- Mid-level
- US work authorization
Quick Apply
Digital Website Content Writer
Software Technology Inc —Remote
- Full-time
- Remote
- Background check
- Marketing
- Mid-level
Quick Apply
Web Content Strategy Writer
Loma Linda University Health —Loma Linda, CA
- $32.25 - $43.38 an hour
- Full-time
- Microsoft Outlook
- Marketing
- 5 years
Freelance Script Writer
Filmless —New York, NY
- Contract
- Remote
- 5 years
- Senior level
- Editing
- Work from home
Quick Apply
Freelance Content Writer, DMS
Front Row Group —New York, NY
- $15 an hour
- Hybrid work
- Research
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Regulatory Writer and/or Regulatory QC/ Editor
Vir Biotechnology —Remote
- $90 - $120 an hour
- Remote
- 5 years
- Mid-level
- Analysis skills
Quick Apply
Temporary Grant Writer (Part time)
Global Refuge —Baltimore, MD
- From $36 an hour
- Temporary
- Remote
- Microsoft Excel
- Microsoft Outlook
- Mid-level
Quick Apply
5d

I want to receive the latest job alert for Writer Needed

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Technical Writer

Fresenius Kabi -
Pleasant Prairie, WI

Quick Apply

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

Refine Your Search

Writer Needed jobs

Technical Writer

Clinical Medical Writer Consultant

Creative Writer – Weekly Blogging Program (Contract)

Writer

Proofreader

Fantasy Football Writer/Content Creator

Contract Writer - The Western Journal - News

Contract Writer - The Western Journal - Opinion/Commentary

Academic Book Indexer (Humanities & Social Sciences)

Senior Writer

Proposal Writer

Writer/Digital Content Creator

Content Writer

Communications Analyst (Contract)

Digital Website Content Writer

Web Content Strategy Writer

Freelance Script Writer

Freelance Content Writer, DMS

Regulatory Writer and/or Regulatory QC/ Editor

Temporary Grant Writer (Part time)

I want to receive the latest job alert for Writer Needed

Related Searches

Explore jobs in more locations

Job Summary

Responsibilities

Additional Information

Job Seeker Tools

Employer Tools

Browse

Stay Connected