Quality Assurance Document Control
2 weeks ago
Job Description: Top Skills:
- 2+ years of Document Control & Reporting Experience,
- Veeva experience preferred
- Technical troubleshooting
- Self motivated, independent, great communication
- Experience working cross-functionally
Position Summary:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.
Duties/Responsibilities:
Primary responsibilities include:
• Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
• May write and revise document control procedures including participating in the development and roll-out of document control tools.
• Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
Education: Bachelor’s degree or equivalent
Experience Basic Qualifications:
• Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
• Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
• Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
• Experience interacting with FDA or other regulatory agencies strongly preferred.
• Strong knowledge of cGMPs and domestic regulatory requirements.
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
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