
Clinical Quality Assurance Professional
2 weeks ago
Quality Assurance Specialist
About the RoleWe are seeking a seasoned Quality Assurance Specialist to provide day-to-day support for clinical quality assurance activities across ongoing clinical trials.
Key Responsibilities:- Serve as the primary QA resource for clinical study teams, ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.
- Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings.
- Develop and maintain 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.
- Collaborate with cross-functional stakeholders to align on quality expectations and risk mitigation.
- 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.
This is a full-time contract role offering 30-40 hours per week of consistent work. The contractor will act as a core member of the QA function, providing essential support to ongoing clinical programs and ensuring regulatory compliance.
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