GMP Document Control Specialist

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 34,000 - 48,000; Full time

Job summary

KBI Biopharma, Inc. seeks a Document Control Coordinator I/II to manage controlled documentation lifecycle, including issuance, review, approval, and archival in GxP environments.

You will support GMP compliance across manufacturing, QA, and regulatory activities for internal stakeholders and clients. Responsibilities include issuing records, maintaining forms and logbooks, processing documents in EDMS, and assisting during audits and inspections.

Qualifications

• Associate degree in a discipline relevant to document control, quality systems, regulated operations, or equivalent experience.
• Typically 1–3 years of experience in document control, quality, records management, or a GMP-regulated environment.
• Bachelor’s degree in a discipline relevant to document control, quality systems, regulated operations, or equivalent experience.
• Typically 3–5 years of experience in document control, quality, records management, or a GMP-regulated environment.
• 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 as applicable.
• Process and maintain cGMP documentation within the electronic document management system (EDMS).
• Issue manufacturing records and documentation to support production activities.
• Create, issue, maintain, and reconcile controlled forms, logbooks, and related documentation.
• Scan, organize, and archive controlled documents to ensure accurate records retention and retrieval.
• Coordinate document review and approval workflows with internal stakeholders and clients.
• Manage off-site document storage and retrieval activities.
• Fulfill documentation requests from internal and external customers in a timely manner.
• Support internal audits, client audits, and regulatory inspections by providing requested documentation.

Skills

Document control

GMP knowledge

EDMS

Attention to detail

Written/verbal comms

Cross-functional

Education

AS/AA in related field

BS in related field

Job description

KBI Biopharma, Inc. seeks a Document Control Coordinator I/II to manage controlled documentation lifecycle, including issuance, review, approval, and archival in GxP environments.

You will support GMP compliance across manufacturing, QA, and regulatory activities for internal stakeholders and clients. Responsibilities include issuing records, maintaining forms and logbooks, processing documents in EDMS, and assisting during audits and inspections.