The posting
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.
Key responsibilities include issuing manufacturing records, maintaining controlled forms and logbooks, processing documents within the electronic document management system (EDMS), coordinating document review and approval workflows, supporting document archival and off-site storage, responding to documentation requests, and assisting during internal audits, client audits, and regulatory inspections. The position serves as a liaison between internal departments, Quality Assurance, production teams, and clients to ensure timely and compliant document management activities.
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: $24.73 - $35.00
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.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
