Quality Assurance Specialist
Core
Ensuring quality compliance and documentation integrity for clinical laboratory operations and device history records.
Role type
Quality Assurance Specialist (Clinical Lab Operations)
Builds
Quality documentation, compliance reports, and corrective action plans for clinical testing environments.
Domain
Healthcare / Clinical Laboratory / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Regulatory compliance knowledge (CLIA/CAP/FDA), documentation management, root cause analysis, metrics reporting, SOP maintenance, audit preparation, workflow creation, data organization
Preferred skills
Science or Engineering degree, experience in CAP/CLIA/NYS/FDA regulated labs, process improvement, cross-functional collaboration
Technologies
Electronic Quality Management Systems, Microsoft Office, Google Suite
Responsibilities
Compile and approve Device History Records, manage incoming material acceptance, maintain SOPs and quality documentation, conduct root cause analysis for quality issues, report deviations to management, facilitate corrective and preventative actions, track quality records and training matrices, assist in document control workflows.
Seniority
Mid-level, hands-on IC