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2 days ago
We are seeking a highly skilled QA professional to provide daily clinical quality assurance support across ongoing clinical trials.
- Acts as the primary QA resource for clinical study teams, ensuring adherence to 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.
- Develops, reviews, updates, and formats standard operating procedures (SOPs) and other quality documentation.
- Manages and tracks quality processes within a quality management system, including document control, training, and CAPA management.
- Responds to QA-related questions from study teams in real-time, providing clear and actionable guidance.
- Supports inspection readiness and contributes to continuous improvement of QA systems and processes.
- Bachelor's degree in life sciences, healthcare, or a related field (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 a quality management system.
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