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6 days ago
We are seeking a skilled Quality Assurance Specialist to provide day-to-day clinical quality assurance support across ongoing clinical trials.
- The ideal candidate brings strong experience with Veeva QMS, is highly tech-savvy, and can support clinical operations teams in a fast-paced environment.
- Serves as the primary QA support resource for clinical study teams, ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.
- Provides QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
- Documentation Management: Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
- Veeva QMS Management: Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
- QA Support: Address QA-related questions from study teams in real time, providing clear and actionable guidance.
- Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
- 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
- Prior experience supporting clinical study teams in a QA capacity.
- Hands-on experience with Veeva QMS.
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