Clinical Laboratory Quality Analyst
Core
Maintain and support the laboratory Quality Management System (QMS) to ensure compliance with regulatory standards and drive continuous improvement in clinical testing operations.
Role type
Quality Assurance Analyst (Clinical Laboratory)
Builds
Quality dashboards, reports, and corrective action plans for laboratory operations
Domain
Healthcare diagnostics / Clinical Laboratory Science
Deliverable
dashboards & analysis
Required skills
Regulatory compliance (CLIA, CAP, ISO 15189), Root cause analysis, Statistical trend analysis, CAPA management, Process optimization, Data interpretation
Preferred skills
Data analysis, Quality management initiatives, Electronic data management systems
Technologies
MasterControl, Laboratory Information Systems
Responsibilities
Monitor compliance with policies and regulatory requirements; Track and trend nonconformances and deviations; Collect and analyze laboratory quality data; Develop dashboards and reports for quality metrics; Perform root cause analysis; Support internal and external audits; Maintain quality documentation and SOPs; Coordinate proficiency testing.
Seniority
Mid-level, hands-on IC