QA Documentation Specialist - I

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

Additional Information

All your information will be kept confidential according to EEO guidelines.