GMP Document Control Coordinator I/II - Lifecycle & Audits

KBI Biopharma, Inc.

Colorado

On-site

USD 34,000 - 48,000

Full time

3 days ago

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Job summary

KBI Biopharma, Inc. is seeking a detail‑oriented Document Control Coordinator I/II to manage GMP‑controlled documents throughout their lifecycle, support audits, and ensure accurate records for internal teams and clients.

The role emphasizes timely issuance, review, archival, and retrieval to uphold data integrity and regulatory compliance. You will coordinate cross‑functional document workflows, maintain EDMS and paper files, respond to documentation requests, and assist with inspections and

Qualifications

Associate or Bachelor’s degree in a discipline related to document control, quality systems, or regulated operations.
1–3 years (Coordinator I) or 3–5 years (Coordinator II) in GMP‑regulated document control.
Experience with electronic document management systems preferred.

Responsibilities

Manage electronic and paper‑based controlled documents throughout their lifecycle, including issuance, review, archival, retrieval, and destruction.
Process and maintain cGMP documentation within the EDMS.
Issue manufacturing records and documentation to support production activities.
Create, issue, maintain, and reconcile controlled forms and logbooks.
Scan, organize, and archive controlled documents for retention and retrieval.
Coordinate document review and approval workflows with internal stakeholders and clients.
Support internal and external documentation requests and audits.