Document Control Coordinator I

KBI Biopharma • Durham, NC

1d

About The Position

The Document Control Coordinator I / II is responsible for the review, control, issuance, distribution, and archival of cGMP documentation in support of regulated manufacturing and quality operations. This position ensures documentation accuracy, compliance with cGMP requirements, and adherence to internal documentation standards and procedures. The role includes coordination with internal departments, Quality Assurance, technical teams, and external clients, as applicable, and provides support during regulatory inspections and client audits. Essential Duties and Responsibilities Perform reviews of cGMP documents within the Electronic Document Management System (EtQ) in preparation for Department, Technical, Quality Assurance, and client review and approval, as applicable. Manage the EDMS and paper-based controlled document systems, ensuring accurate tracking, version control, and compliance with documentation SOPs. Review controlled documents routed for approval to verify conformance with documentation standards and formatting requirements; perform minor administrative or formatting changes as needed. Control the issuance, receipt, reconciliation, and archival of cGMP documentation. Issue manufacturing records for each project or campaign in accordance with approved procedures and schedules. Image controlled documents for electronic archival in an organized manner to ensure ease of reference and retrieval. Archive hard-copy controlled documents in an organized fashion and prepare records for off-site storage in accordance with record retention requirements. Transmit controlled documents to clients for approval and reference and communicate document review status and cloud-based updates when applicable. Create, issue, and maintain controlled forms, including logbooks and related documentation, for applicable departments. Fulfill documentation requests from internal and external customers in a timely and accurate manner, including support for client audits and regulatory inspections. Assist during regulatory and client audits by retrieving requested documentation and responding to document control–related inquiries. Demonstrate flexibility and the ability to respond productively to changing priorities and perform other essential duties as assigned.

Requirements

• AAS, BS, BA or MS degree.
• 1-2 years of experience in a QA or GMP environment, or equivalent, is preferred but not required.
• Experience with electronic document management systems desired.
• Conveys information clearly and concisely, both orally and in writing.
• Records (accurately, clearly, and consistently) information, facts, and measurements that are required by cGMP and/or by co-workers in order to understand situations and to perform their assignments.
• Interfaces professionally, effectively, and efficiently with all levels of management, coworkers, and outside vendors
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Understands implications of non-compliant results.
• Strong attention to detail.
• Ability to interpret an extensive variety of technical instructions and prioritize tasks accordingly.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job the employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl; talk or hear. The employee is occasionally required to lift up to 35 pounds. The vision requirements include: close vision and distance vision.
• Intermediate proficiency in Microsoft Office applications (Word, Excel), Adobe, and email systems (i.e., Outlook, Google, etc.);
• Experience in web applications

Nice To Haves

• Experience with electronic document management systems desired.

Responsibilities

• Perform reviews of cGMP documents within the Electronic Document Management System (EtQ) in preparation for Department, Technical, Quality Assurance, and client review and approval, as applicable.
• Manage the EDMS and paper-based controlled document systems, ensuring accurate tracking, version control, and compliance with documentation SOPs.
• Review controlled documents routed for approval to verify conformance with documentation standards and formatting requirements; perform minor administrative or formatting changes as needed.
• Control the issuance, receipt, reconciliation, and archival of cGMP documentation.
• Issue manufacturing records for each project or campaign in accordance with approved procedures and schedules.
• Image controlled documents for electronic archival in an organized manner to ensure ease of reference and retrieval.
• Archive hard-copy controlled documents in an organized fashion and prepare records for off-site storage in accordance with record retention requirements.
• Transmit controlled documents to clients for approval and reference and communicate document review status and cloud-based updates when applicable.
• Create, issue, and maintain controlled forms, including logbooks and related documentation, for applicable departments.
• Fulfill documentation requests from internal and external customers in a timely and accurate manner, including support for client audits and regulatory inspections.
• Assist during regulatory and client audits by retrieving requested documentation and responding to document control–related inquiries.
• Demonstrate flexibility and the ability to respond productively to changing priorities and perform other essential duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree