Quality Control Specialist
Core
Ensures quality and safety standards in a clinical laboratory by performing routine and non-routine quality control reviews of diagnostic assays, equipment, and SOPs, while analyzing QC trends and managing deviations.
Role type
Quality Control Specialist (Clinical Laboratory)
Builds
Diagnostic assays, laboratory equipment, and validated testing methods for clinical diagnostics clients.
Domain
Clinical diagnostics / In-vitro diagnostics / Laboratory services
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, statistical data analysis, technical writing, study design, regulatory compliance knowledge (CLIA, CAP, FDA, ISO 15189), laboratory instrument proficiency, CAPA process management, deviation handling, data analytics.
Preferred skills
Project management, quality audit participation, method validation testing knowledge, troubleshooting.
Technologies
LIMS, electronic analysis and tracking systems, laboratory instruments.
Responsibilities
Perform routine and non-routine quality control review of diagnostic assays, equipment, and SOPs; Analyze QC trends, identify deviations, and escalate issues; Participate in root cause investigations and implement corrective/preventive actions (CAPAs); Assist with validation and verification of new instruments and diagnostic assays; Maintain accurate records in accordance with regulatory guidelines; Participate in quality audits or regulatory inspections; Support training efforts for laboratory personnel.
Seniority
Mid-level, hands-on IC
