- 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.
- Document Management System experience required.
- Pharma background preferred
All your information will be kept confidential according to EEO guidelines.
