QA Documentation Specialist - I

- 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. - Intake Notes: - Document Management System experience required. - Pharma background preferred - Process high volume - Detailed oriented All your information will be kept confidential according to EEO guidelines.