GMP Technical Writer – QMS & Investigations (Onsite)

Pace Analytical Life Sciences; Oakdale (MN); In loco; USD 70.000 - 95.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision

401K retirement plan

Paid time off

Descrizione del lavoro

Pace Life Sciences in Oakdale, MN is hiring a Technical Writer onsite. You will author, update, and manage GMP documentation within a regulated contract testing environment, coordinating with Operations, Laboratory, and Quality Assurance to ensure inspection readiness and compliance with cGMP and data integrity standards.

This full-time role offers strong growth and a comprehensive benefits package. Qualified candidates have a Bachelor’s in Life Sciences and 3+ years in GMP settings, with

Competenze

• Bachelor’s degree in Life Sciences or related field with 3+ years in regulated environment.
• Familiarity with cGMP, GDP, and FDA regulatory expectations.
• Strong writing, editing, and formatting of technical documentation.

Mansioni

• Author, edit, and maintain GMP documentation, SOPs, forms, and quality records.
• Coordinate and draft investigation reports, deviations, CAPAs, change controls, complaints, and OOS/OOT docs.
• Translate complex data into clear, scientifically sound technical documentation.
• Ensure compliance with FDA cGMP, data integrity, ICH guidelines, and internal standards.
• Lead or support root cause analyses and CAPA development.
• Collaborate with cross-functional teams to resolve documentation issues.
• Manage document review, approval, version control, and archival in the eQMS.
• Support audit readiness and responses, and drive continuous improvement.
• Monitor quality metrics related to investigations and changes for management review.
• Contribute to department efficiency and customer service excellence.
• Promote Pace’s mission in interactions with customers and staff.

Conoscenze

Technical writing

Quality systems

Document control

Root cause analysis

Cross-functional collaboration

Formazione

Bachelor’s degree in Life Sciences or related

Strumenti

Microsoft Office

eQMS

Descrizione del lavoro

Pace Life Sciences in Oakdale, MN is hiring a Technical Writer onsite. You will author, update, and manage GMP documentation within a regulated contract testing environment, coordinating with Operations, Laboratory, and Quality Assurance to ensure inspection readiness and compliance with cGMP and data integrity standards.

This full-time role offers strong growth and a comprehensive benefits package. Qualified candidates have a Bachelor’s in Life Sciences and 3+ years in GMP settings, with