The Document Control Specialist administers the Quality Management System (QMS), document control, quality records and reporting, training administration, calibration programs, audit support, and quality compliance activities. The role serves as the functional administrator for the electronic quality system and database (QCBD), maintaining system effectiveness, data integrity, workflows, training records, controlled documents, and audit readiness. The specialist compiles and analyzes quality data from QCBD, CERM, ePace, audits, customer complaints, nonconformances, training records, and other sources. The position develops KPI reports, dashboards, and trend analyses to identify recurring issues, emerging risks, and improvement opportunities. It also maintains FSC documentation, administers GMP and quality compliance training, and manages records and programs such as document revision control, CAPA tracking, audits, investigations, equipment calibration and validation, and supplier qualification. The role supports audits, inspections, investigations, and management reviews by preparing records, coordinating requests, and working with cross-functional teams. It facilitates continuous process improvement by analyzing quality, audit, customer feedback, nonconformance, safety incident, and process performance data to identify trends and support sustainable corrective and preventive actions. The specialist collaborates with Quality, Operations, and other departments to support accurate documentation and compliance with customer, ISO 9001, GMP, and company requirements. Other duties may be assigned.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED