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Job Overview
We are seeking a highly skilled Quality Assurance Specialist to provide day-to-day clinical quality assurance support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight.
Key Responsibilities
- Serve as the primary QA support resource for clinical study teams, ensuring compliance with 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
- 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.
- Partner with cross-functional stakeholders (Clinical Operations, Data Management, Regulatory, etc.) to align on quality expectations and risk mitigation.
Required Skills and Qualifications
- Education: Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
- Experience:
- 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.
- Technical Skills:
- Proficient in MS Office (Excel, PowerPoint, Word).
- Skilled in technical writing, SOP drafting, and document formatting.
- Soft Skills:
- Excellent communication and interpersonal skills.
- Strong organizational skills with the ability to work independently.
What We Offer
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.
