Senior Quality Assurance Specialist
Core
Documenting and tracking compliance for a clinical molecular laboratory, supporting quality assurance activities for FDA QMSR, ISO 13485, CLIA/CAP, and other global regulations.
Role type
Senior Quality Assurance Specialist (Clinical Laboratory)
Builds
Quality management systems and compliance documentation for clinical molecular testing
Domain
Healthcare / Clinical Molecular Laboratory / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Records management, SOP creation and revision, root cause analysis, corrective and preventative action implementation, supplier documentation compliance, audit preparation, deviation reporting
Preferred skills
Experience in CAP/CLIA/NYS/FDA regulated clinical labs
Technologies
Microsoft Office, Google Suite
Responsibilities
Compile and approve Device History Records, perform incoming material acceptance, maintain quality documentation for regulatory satisfaction, provide metrics for trend identification and root cause analysis, report significant deviations, coordinate quality tasks with management and testing personnel, pull records for internal and external audits, manage supplier documentation and compliance
Seniority
Mid-level, hands-on IC