GMP Technical Writer – QMS & Compliance

Pace Analytical Services, LLC; Oakdale (MN); On-site; USD 55,000 - 65,000; Full time

Job summary

Pace Life Sciences in Oakdale, MN is seeking a full-time onsite Technical Writer to author, coordinate, and maintain GMP documentation and quality records in a regulated contract testing laboratory environment. You will collaborate with Operations, Laboratory, QA, and Program Management to ensure documents are accurate, inspection-ready, and compliant with cGMP and data integrity requirements.

Ideal candidates have a Bachelor's in Life Sciences or related field and 3+ years in regulated

Qualifications

• Bachelor's degree in Life Sciences, QA, Technical Communication, or related field.
• 3+ years of experience in pharmaceutical, medical device, cGMP, or other regulated environment.
• Familiarity with cGMP, GDP principles, and FDA regulatory expectations.

Responsibilities

• Author, edits, and maintains GMP documentation, SOPs, forms, and quality records.
• Drafts investigations, deviations, CAPAs, change controls, and OOS/OOT documentation.
• Translates complex data into clear, scientifically sound documentation.
• Ensures compliance with FDA cGMP, data integrity, and internal standards.
• Leads or supports root cause analyses and CAPA development.

Skills

Authoring & editing docs

Technical writing

Documentation formatting

Education

Bachelor's degree in Life Sciences / QA / Technical Communication

Tools

Microsoft Office

Electronic quality management systems

Job description

Pace Life Sciences in Oakdale, MN is seeking a full-time onsite Technical Writer to author, coordinate, and maintain GMP documentation and quality records in a regulated contract testing laboratory environment. You will collaborate with Operations, Laboratory, QA, and Program Management to ensure documents are accurate, inspection-ready, and compliant with cGMP and data integrity requirements.

Ideal candidates have a Bachelor's in Life Sciences or related field and 3+ years in regulated