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3 days ago
We are seeking an experienced 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.
- As the primary QA support resource, ensure compliance with Good Clinical Practice (GCP) and internal quality standards during study calls, including protocol deviation meetings, risk-based quality management discussions, and trial oversight meetings.
- Provide QA expertise by writing, reviewing, updating, and formatting standard operating procedures (SOPs) and other quality documentation.
- Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
- Offer clear and actionable guidance on QA-related questions from study teams in real time.
- Contribute to inspection readiness and continuous improvement of QA systems and processes.
Prior experience supporting clinical study teams in a QA capacity, hands-on experience with Veeva QMS, technical writing skills, and proficiency in MS Office are required. Excellent communication and interpersonal skills, strong organizational skills, and ability to work independently are desired.
This is a full-time contract role offering 30–40 hours per week of consistent work. As a core member of the QA function, you will provide essential support to ongoing clinical programs and ensure regulatory compliance.
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