QA Documentation Specialist - I
About this role
Company Description
Job Description
- 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
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.
Frequently Asked Questions
Is the salary disclosed for the QA Documentation Specialist - I position at integratedresourcesinc?
The salary for this QA Documentation Specialist - I role at integratedresourcesinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the QA Documentation Specialist - I position at integratedresourcesinc located?
This QA Documentation Specialist - I role at integratedresourcesinc is based in CA, Foster City, Foster City, CA, United States, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the QA Documentation Specialist - I role at integratedresourcesinc full-time or part-time?
This is listed as a Contract position. It is posted as a QA Documentation Specialist - I role at integratedresourcesinc.
How do I apply for the QA Documentation Specialist - I position at integratedresourcesinc?
Click the "Apply Now" button on this page. You will be redirected to integratedresourcesinc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the QA Documentation Specialist - I job at integratedresourcesinc posted?
This QA Documentation Specialist - I position at integratedresourcesinc was posted on Aug 3, 2017. Apply as soon as possible — early applications are often reviewed first.
QA Documentation Specialist - I
integratedresourcesinc
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