Onsite GMP Technical Writer – Quality & Compliance

Pace® Analytical Services; Oakdale (MN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K with company match

Paid time off

HSA / Wellness program

Tuition reimbursement

Job summary

Pace® Life Sciences seeks a Technical Writer to author, coordinate, and maintain GMP documentation in a regulated contract testing laboratory environment in Oakdale, MN. You will produce SOPs, work instructions, CAPAs, investigations, deviations, and change controls, ensuring accuracy and inspection readiness.

Collaborating with Operations, Laboratory, and QA, you will translate complex lab and process data into clear documentation, support audits, and drive continuous improvement within a

Qualifications

• Bachelor’s degree in Life Sciences or related field with 3+ years in regulated environments.
• Familiarity with cGMP, GDP, and FDA regulatory expectations required.
• Experience creating and maintaining GMP documentation and SOPs.

Responsibilities

• Author, revise, and maintain GMP documentation including SOPs, work instructions, forms, and training materials.
• Draft and coordinate investigation reports, deviations, CAPAs, and change controls.
• Translate complex lab data into clear, compliant written documentation.
• Ensure documentation complies with FDA/cGMP, data integrity, and ICH guidance.
• Support internal and regulatory audits and continuous improvement initiatives.
• Collaborate with cross‑functional teams to resolve documentation issues.

Skills

GMP documentation

GDP principles

FDA regulatory expectations

QMS documentation

Document control procedures

Root cause analysis

Laboratory and operational processes

Microsoft Office

Electronic document management systems

Written English

Education

Bachelor's degree in Life Sciences

Tools

MS Office

eQMS / DMS

Job description

Pace® Life Sciences seeks a Technical Writer to author, coordinate, and maintain GMP documentation in a regulated contract testing laboratory environment in Oakdale, MN. You will produce SOPs, work instructions, CAPAs, investigations, deviations, and change controls, ensuring accuracy and inspection readiness.

Collaborating with Operations, Laboratory, and QA, you will translate complex lab and process data into clear documentation, support audits, and drive continuous improvement within a