GMP Quality Documentation Writer – QMS Specialist

Pace® Analytical Services; Oakdale (MN); In loco; USD 55.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Benefits program

401K retirement plan

Paid time off

Descrizione del lavoro

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

Collaboration with Operations, Laboratory, QA, and PM teams to develop and manage SOPs, investigations, CAPAs, and change controls ensures data integrity and inspection readiness. Qualified candidates possess a Life Sciences degree and 3+ years in a regulated environment, with strong documentation, QA,

Competenze

• GMP, GDP, FDA regulatory expectations familiarity.
• GCP not required but helpful.
• Experience in a cGMP or regulated environment preferred.

Mansioni

• Author, edit, and maintain controlled GMP documentation including SOPs and training materials.
• Draft and coordinate investigation reports, deviations, CAPAs, and change controls.
• Translate complex data into clear, scientifically sound documentation.
• Ensure compliance with FDA cGMP, data integrity and internal quality standards.
• Lead or support root cause analyses and CAPA development.
• Collaborate with cross-functional teams to resolve documentation issues.

Conoscenze

GMP documentation

cGMP compliance

Quality Assurance

Documentation control

Data integrity

Root cause analysis

SOP drafting

Regulatory submissions

Formazione

Bachelor's degree in Life Sciences

Strumenti

MS Office

Electronic document management systems

Electronic quality management systems

Descrizione del lavoro

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

Collaboration with Operations, Laboratory, QA, and PM teams to develop and manage SOPs, investigations, CAPAs, and change controls ensures data integrity and inspection readiness. Qualified candidates possess a Life Sciences degree and 3+ years in a regulated environment, with strong documentation, QA,