GMP Documentation & Records Specialist

Guerbet; Raleigh (NC); On-site; USD 48,000 - 64,000; Full time

Job summary

Guerbet is seeking a Documentation Assistant to support GMP documentation throughout the lifecycle, ensuring accuracy, compliance, and alignment with regulatory requirements. You will format, edit, proofread, route, issue, and archive GMP‑controlled documents, while maintaining records and assisting with inquiries across cross‑functional teams.

This role contributes to continuous improvement of the document control process in a regulated medical environment, supporting audits and timely

Qualifications

• 2–4 years of experience supporting document control in a GMP-regulated environment.

Responsibilities

• Coordinate the preparation, review, revision, and maintenance of GMP-controlled documents throughout the document lifecycle.

Skills

Document control

Microsoft Office

EDMS

Attention to detail

Organizational skills

Education

Associate’s or Bachelor's degree

Tools

EDMS

LMS

QMS

Job description

Guerbet is seeking a Documentation Assistant to support GMP documentation throughout the lifecycle, ensuring accuracy, compliance, and alignment with regulatory requirements. You will format, edit, proofread, route, issue, and archive GMP‑controlled documents, while maintaining records and assisting with inquiries across cross‑functional teams.

This role contributes to continuous improvement of the document control process in a regulated medical environment, supporting audits and timely