Quality and Compliance Systems Specialist
About the position Interpath Laboratory is seeking a Laboratory Quality and Compliance Specialist to lead quality assurance and regulatory compliance programs at our headquarters laboratory. You'll independently manage proficiency testing, monitor quality control performance, and ensure adherence to CLIA, CAP, and state regulations. This role offers genuine autonomy: you'll interpret regulatory requirements, scope internal audits, evaluate root causes, and formulate corrective actions. You'll also champion the innovative use of AI tools and automation to strengthen our quality systems, reduce manual effort, and enhance compliance readiness.
Responsibilities
- Administer proficiency testing programs across all regulated analytes and specialties
- Design and implement automation solutions that reduce manual work while preserving regulatory integrity
- Analyze QC and PT data, identify trends, and track corrective actions to completion
- Conduct internal audits and prepare for regulatory inspections (CMS, CAP, state agencies)
- Investigate deviations and complaints; determine root causes and implement preventive measures
- Maintain current knowledge of CLIA, CAP, FDA, OSHA, HIPAA, and state regulations
- Support method validation and verification activities
- Leverage AI resources to audit documentation, analyze data, and identify compliance risks proactively
- Collaborate with laboratory leadership and clinical systems staff on quality and compliance initiatives
Requirements
- Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, Chemistry, or related field
- Minimum 3 years in a CLIA-regulated clinical laboratory environment
- Valid driver's license
- Strong analytical and communication skills
- Ability to manage multiple priorities and work independently
- Proficiency in Microsoft Office and document control systems
- Sound judgment in regulated environments
Nice-to-haves
- 2+ years in laboratory QA, compliance, or accreditation activities
- Experience with AI tools (LLMs, document automation, data analysis platforms)
- Laboratory information systems, middleware, or instrument interface experience
- Method validation and statistical QC expertise (Levey-Jennings, Westgard rules)
- ASCP certification (MLS, MLT, CLS) or laboratory quality certification (ASQ CQA, ASCP QLC)
- Experience supporting laboratory inspections or accreditation surveys
Benefits
- Comprehensive benefits package
- Ever-evolving learning and development program which fosters career growth
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