Document Coordinator I

Coordinate the system for changes to controlled GMP documents including SOPs, batch records, and specifications by creating, formatting, revising, issuing, and archiving them in the Quality Document Management System. Issue and reconcile various batch records in accordance with production schedules and approved protocols while maintaining tracking databases and preparing site transfer cases. Scan, upload, and archive batch records, sterilization reports, and test reports in electronic archives per site SOPs and retention requirements. Serve as a document author and subject matter expert for document management processes and support department projects. Support occasional late-night or weekend work based on business needs.