Document Control Specialist

Job Duties:Manage the document control process, including creation, revision, approval, distribution, and archiving of controlled documentsAssign document numbers, ensure timely review and approval of documents and monitor document workflowsEnsure all documents are accurate, up-to-date, and readily accessible.Assist in preparing and maintaining quality records, ensuring completeness, traceability, and accuracy.Support internal and external audits by providing controlled documents, quality records, and other required information.Collaborate with cross-functional teams to identify document gaps and recommend improvements to meet regulatory standards.Manage and monitor employee training records related to controlled documents and QMS processes.Facilitate training sessions to educate employees on document control policies and procedures.Perform receiving and inspections of incoming materials and equipment to verify conformance with specifications and quality standards.Document inspection results and initiate Non-Conformance Material Reports (NCMRs) for any discrepancies.Assist with shipping, labeling, and documentation of outgoing product for traceability and accuracyParticipate in other quality activities as time allows, including non-product software validation, CAPAs, supplier control, equipment IQ/OQ, registration, and calibration activities Professionally interacts and maintains effective and open communication with all personnel, vendors, manufacturers, and customers.Adheres to all applicable department, production, and company related Operational, Safety and Human Resources policies and procedures.

Created: 2025-01-14