Senior Clinical Laboratory Auditor
Core
Lead risk-based Quality System audits across Abbott Clinical Laboratory and manufacturing sites to ensure compliance with global regulations and protect patient safety.
Role type
Senior Clinical Laboratory Auditor (Quality & Regulatory)
Builds
Compliance audit programs and risk assessments for clinical testing operations
Domain
Healthcare diagnostics, Clinical Laboratory Science, Medical Device Regulation
Required skills
Risk-based auditing, Good Clinical Practice (GCP), Regulatory compliance (CLIA, CAP, ISO 17025, ISO 14155, ISO 15189, 21 CFR Part 820/QMSR, ISO 13485, EU MDR), Molecular biology testing, PCR/NGS processes, Bioinformatics analysis, Validation of laboratory-developed tests (LDTs), SOP development, Audit reporting
Preferred skills
Medical Device experience, Vendor audit experience, Experience with regulatory authority inspections
Technologies
PCR, Next-generation sequencing (NGS), Gene expression analysis, DNA mutation analysis, ctDNA analysis, Bioinformatics tools, Immunohistochemistry
Responsibilities
Plan and execute in-depth risk-based Quality System audits; Evaluate compliance with global standards and regulations; Monitor emerging regulatory requirements and industry trends; Review documentation and risk management files for compliance; Identify non-conformities and product/process risks; Write professional audit reports for executive management; Develop and provide professional education on compliance and quality topics.
Seniority
Senior, hands-on IC