Quality Assurance Associate
Core
Documenting and tracking compliance for a clinical molecular laboratory, ensuring adherence to FDA QMSR, ISO 13485, CLIA, and CAP regulations.
Role type
Quality Assurance Associate (Clinical Laboratory Compliance)
Builds
Quality management system documentation and regulatory compliance records
Domain
Healthcare / Clinical Molecular Laboratory / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Records management, SOP interpretation, deviation reporting, corrective and preventative action (CAPA) support, supplier documentation review, audit preparation
Preferred skills
Clinical lab experience (CAP/CLIA/NYS/FDA), process creation, problem-solving
Technologies
Microsoft Office, Google Suite
Responsibilities
Compile Device History Records, maintain quality records and binders, report significant deviations, pull records for internal/external audits, manage supplier documentation and compliance
Seniority
Junior, entry-level IC