GMP Document Control Specialist

polypeptideus; Torrance (CA); On-site; USD 41,328 - 49,593; Full time

Job summary

PolyPeptide in Torrance, CA seeks a detail-oriented Document Control Coordinator to support production documentation in a cGMP environment. This role focuses on accurate review of production records, corrections, deviation closure, and maintaining compliant documentation practices across Manufacturing, Quality, and cross-functional teams.

You will review records, assist with corrections, and help ensure timely documentation while coordinating with multiple groups to uphold quality standards and

Qualifications

• 2+ years of experience in a GMP-regulated manufacturing or quality environment.
• Familiarity with cGMP, GDP, and FDA/ICH guidelines.
• Proficiency with Microsoft Office (Word, Excel, Outlook).

Responsibilities

• Review manufacturing documentation for accuracy, completeness, and compliance.
• Perform document and change control review activities with minimal supervision.
• Support person-in-plant documentation review, as needed.
• Facilitate GDP corrections for documentation errors.
• Initiate and assist with the closure of process deviations.
• Help establish and maintain systems that support timely documentation review and prioritization.
• Partner with Production Leads and Supervisors to support NC and GDP improvements.
• Communicate with Production management regarding process or performance issues.
• Coordinate with cross-functional teams to support implementation of changes.
• Assist with creating and updating SOPs and forms related to document control processes.
• Provide documentation mentoring and coaching to Production personnel.
• Perform additional duties as assigned.

Skills

Attention to detail

Documentation accuracy

Organization

Analytical skills

Cross-functional communication

Education

Associate or Bachelor's degree in life sciences

Tools

Microsoft Office (Word, Excel, Outlook)

Job description

PolyPeptide in Torrance, CA seeks a detail-oriented Document Control Coordinator to support production documentation in a cGMP environment. This role focuses on accurate review of production records, corrections, deviation closure, and maintaining compliant documentation practices across Manufacturing, Quality, and cross-functional teams.

You will review records, assist with corrections, and help ensure timely documentation while coordinating with multiple groups to uphold quality standards and