GMP QA Technical Writer - Documentation Expert

Pacelabs; Oakdale (MN); On-site; USD 55,000 - 65,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

Job summary

Pace Life Sciences is seeking a Technical Writer for on-site work in Oakdale, MN. You will author, revise, and maintain GMP documentation supporting compliant operations in a regulated lab environment.

Responsibilities include coordinating investigations, CAPAs, change controls, and SOPs, and translating complex data into clear documentation. A Life Sciences/QA/technical communication background is required.

Qualifications

• Authoring, editing, and formatting clear, concise, accurate, and scientifically sound technical documentation.
• Managing multiple document workflows and timelines in a fast-paced contract testing environment.
• Organizing documentation with strong attention to detail and accuracy.
• Applying root cause analysis tools to investigations and supporting CAPA development.
• Translating complex laboratory and operational data into compliant written procedures.

Responsibilities

• Authoring, editing, and maintaining controlled GMP documentation (SOPs, forms, training materials).
• Drafts, edits, and coordinates investigation reports, deviations, CAPAs, change controls, complaints, and OOS/OOT documentation.
• Translates complex laboratory, operational, and quality data into clear, concise documentation.
• Ensures documentation complies with FDA cGMP, data integrity requirements, and internal standards.
• Supports internal, client, and regulatory audit readiness and continuous improvement initiatives.

Skills

Technical writing

Project management

Attention to detail

Root-cause analysis

Process translation

Cross-functional collaboration

MS Office

Data interpretation

Teamwork

Education

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

Tools

eQMS

Job description

Pace Life Sciences is seeking a Technical Writer for on-site work in Oakdale, MN. You will author, revise, and maintain GMP documentation supporting compliant operations in a regulated lab environment.

Responsibilities include coordinating investigations, CAPAs, change controls, and SOPs, and translating complex data into clear documentation. A Life Sciences/QA/technical communication background is required.