Document Control Coordinator I/II

KBI Biopharma, Inc.; Colorado; On-site; USD 34,000 - 48,000; Full time

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.

Skills

Document control

GMP compliance

EDMS

Records management

Audit support

Cross-functional collaboration

Attention to detail

Communication

Education

Associate degree

Bachelor's degree

Tools

EDMS

Job description

Position Summary

Supports GMP-compliant document control processes by managing controlled documentation, coordinating review and approval workflows, maintaining electronic and paper records, supporting audits and inspections, and ensuring accurate, timely document management for internal stakeholders and clients. The Document Control Coordinator I/II is responsible for managing and maintaining cGMP-controlled documentation throughout its lifecycle, including issuance, review, approval, archival, retrieval, and storage. This role supports manufacturing operations, quality systems, regulatory compliance, and client requirements by ensuring document accuracy, integrity, and accessibility within both electronic and paper-based document management systems.

Core Responsibilities

• Manage electronic and paper-based controlled documents throughout their lifecycle, including issuance, review, approval, 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 and responding to document control-related inquiries.
• Maintain document accuracy, completeness, and compliance with GMP and company requirements.

Core Competencies

• Knowledge of document control principles and records management practices.
• Understanding of GMP regulations, quality systems, and data integrity requirements.
• Proficiency with electronic document management systems (EDMS).
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines.
• Effective written and verbal communication skills.
• Customer-focused approach with strong service orientation.
• Ability to collaborate effectively across departments and with external clients.
• Problem-solving and continuous improvement mindset.
• Ability to work independently while maintaining accuracy and compliance.

Experience Requirements

Document Control Coordinator I

• 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.
• Experience with electronic document management systems preferred.
• Demonstrated organizational skills and attention to detail.

Document Control Coordinator II

• 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 required.
• Demonstrated ability to work independently and manage complex document control activities.
• Experience supporting audits, inspections, and cross-functional document workflows preferred.

Salary

Salary: $24.73 - $35.00

EEO Statement

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

About KBI

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.