
Quality Assurance Role
2 weeks ago
The role of a Quality Assurance Specialist is to provide critical support to clinical study teams ensuring compliance with regulatory requirements and internal quality standards.
- Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
- Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
- Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
- Address QA-related questions from study teams in real-time, providing clear and actionable guidance.
- Support inspection readiness and contribute to continuous improvement of QA systems and processes.
The ideal candidate will have a strong foundation in GCP and hands-on experience with Veeva QMS. They will be able to work independently and as part of a team to ensure regulatory compliance and provide timely QA support.
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Quality Assurance Specialist
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