Senior GxP Technical Writer — Document Control Lead

BioSpace; Pleasant Prairie (WI); On-site; USD 37,746 - 61,192; Full time

Benefits offered by this job

401(k)

Pension

Medical/Dental/Vision coverage

Vacation benefits

Wellness programs

Job summary

A leading global biopharmaceutical company in Kenosha County, Wisconsin, is seeking a Senior Technical Writer to support GxP documentation for its Quality Management System (QMS). The ideal candidate will possess skills in technical writing and document management, with a minimum of 3 to 5 years' experience in a regulated environment preferred. This role involves creating standard operating procedures and collaborating with experts to ensure compliance with regulatory requirements. A comprehensive benefits package is offered, including a competitive hourly rate and potential bonuses.

Qualifications

• 3 to 5 years in a regulated environment.
• Thorough knowledge of Document Management practices.
• Ability to learn different computer systems.

Responsibilities

• Create and revise standard operating procedures.
• Perform gap assessments for compliance.
• Collaborate with subject matter experts.

Skills

Technical writing

Interpersonal skills

Document management

Microsoft Office Suite

Attention to detail

Education

High School Diploma or GED or college BA/BS

Tools

MasterControl

TrackWise

Veeva Quality Docs

Job description

A leading global biopharmaceutical company in Kenosha County, Wisconsin, is seeking a Senior Technical Writer to support GxP documentation for its Quality Management System (QMS). The ideal candidate will possess skills in technical writing and document management, with a minimum of 3 to 5 years' experience in a regulated environment preferred. This role involves creating standard operating procedures and collaborating with experts to ensure compliance with regulatory requirements. A comprehensive benefits package is offered, including a competitive hourly rate and potential bonuses.