Compiles and maintains technical documentation such as blueprints, drawings, change orders and specifications. Examines documents to verify completeness and accuracy of data and resolves discrepancies with document originators. Maintains computerized document control records management system and/or hardcopy documents to ensure compliance with all applicable and required standards, including GMP (good manufacturing practice) and QSR (quality system regulation) requirements. Develops and maintains procedures and standards for maintaining documents and change control of documents, including document development, approval, production, distribution and amendment. Plans and directs document and content management life cycles and may work with either structured or unstructured metadata. Primary Purpose Completes specialized document control tasks requiring deep knowledge of systems and standards, ensuring accuracy for high-volume or critical projects. Maintains master records and implements process improvements to enhance efficiency and compliance. Duties and Responsibilities * Serves as a technical resource for document control standards and compliance requirements. * Advises project teams on best practices for document lifecycle management. * Supports automation initiatives for document workflows and version control. * Maintains global or multi-site document retention and security protocols. * Prepares documentation for high-stakes audits and regulatory inspections. * Generates analytics reports to monitor document performance and compliance trends. * Works with IT teams to ensure repository security and system reliability. * Promotes continuous improvement in document control processes through feedback and testing. * Performs other duties as assigned.
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