Processes IT controlled documents such as computer system procedures, forms, specifications and test documentation in the Electronic Document Management System (EDMS) following defined processes/procedures.
Scans, verifies and archives IT records in accordance with record retention requirements. Ensures the consistent application of Good Documentation Practices.
Works with IT staff to establish priorities and deadlines for processing IT documentation.
Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
Performs general word processing tasks and supports the production of IT documentation per document templates and style guides. Assists IT staff design and implement fillable forms and templates.
Ensures the correct and timely implementation of document Change Requests (CR).
Analyzes Change Requests for completeness. Communicates with IT staff to ensure changes are concise and complete.
Routes documents for review and approval in Electronic Document Management System (EDMS). Ensures that review comments, tracked changes, and impacted documents are addressed. Ensures the integrity of document references.
Notifies training coordinators of new and revised IT procedures, ensuring training assignments are updated as required.
Ensures that the periodic review of IT documentation is correctly scheduled, assigned and is completed in a timely manner.
Identifies deviations from document control procedures, notifies IT management and assists with issue resolution.
Provides support for internal and regulatory audits/inspections as required.
Knowledge, Experience and Skills:
Demonstrates working knowledge of Document Control fundamentals, Quality Systems and GXP requirements.
Demonstrates working knowledge of Electronic Document Management Systems (EDMS).
Demonstrates proficiency in Microsoft Office applications and Adobe Acrobat.
Demonstrates detail orientation, with the ability to process high volumes of document Change Requests in a timely, prioritized and compliant manner.
Demonstrates ability to work effectively in a team environment.
Demonstrates strong verbal, written, and interpersonal communication skills.
3+ years of relevant experience in a regulated industry and an AS degree. Experience with IT operations and documentation in the pharmaceutical industry is preferred.