GMP Document Control Coordinator I-II

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 52,000 - 72,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Document Control Coordinator I/II in Boulder, CO to manage cGMP-controlled documents throughout their lifecycle, including issuance, archival, retrieval, and destruction.

You will coordinate EDMS workflows, support internal and client audits and regulatory inspections, and serve as a liaison between QA, production, and customers to ensure timely documentation. This role requires strong attention to detail, organizational skills, and the ability to manage multiple

Qualifications

• Experience with GMP-regulated document control environments.
• Proficiency with EDMS and records management.
• Strong accuracy and ability to manage multiple workflows.

Responsibilities

• Issue manufacturing records and controlled forms.
• Coordinate document review and approvals.
• Archive and retrieve documents for audits and inspections.
• Support internal and client audits and regulatory inspections.

Skills

Attention to detail

Organizational skills

Communication skills

Education

Associate degree in a discipline relevant to document control, quality systems, regulated operations, or equivalent experience

Bachelor's degree in a discipline relevant to document control, quality systems, regulated operations, or equivalent experience

Tools

EDMS

Job description

KBI Biopharma, Inc. is seeking a Document Control Coordinator I/II in Boulder, CO to manage cGMP-controlled documents throughout their lifecycle, including issuance, archival, retrieval, and destruction.

You will coordinate EDMS workflows, support internal and client audits and regulatory inspections, and serve as a liaison between QA, production, and customers to ensure timely documentation. This role requires strong attention to detail, organizational skills, and the ability to manage multiple