Document Control Coordinator I​/II

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.

• 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.

• 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.

• 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.

• 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.

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.