Document Control Coordinator I

Job description

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 documentati...