Specialist, Quality Assurance
Core
Ensuring quality and compliance of clinical work at traditional and decentralized trial sites to support patient safety and data integrity.
Role type
Quality Assurance Specialist (GxP)
Builds
Clinical research trials and health services
Domain
Clinical research / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP regulatory document review, audit execution and tracking, CAPA management, SOP development and maintenance, external audit and inspection support, quality systems administration, regulatory compliance knowledge (21 CFR Part 11/312, ICH GCP E6 R3), site-level quality and data integrity monitoring
Preferred skills
AI project quality support, RFP/RFI support, digital technology engagement
Technologies
QMS platforms
Responsibilities
Conduct comprehensive reviews of study-specific regulatory binders and clinical documents; Execute the yearly corporate audit plan and prepare detailed outcome reports; Partner with research staff and PIs to resolve compliance issues and monitor CAPA plans; Coordinate and provide hands-on operational support for on-site audits and inspections; Maintain internal quality systems, compliance trackers, and operational programs; Participate in the routine review, drafting, and maintenance of quality assurance SOPs; Provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams
Seniority
Mid-level, hands-on IC