Lab Quality Systems Specialist: AI-Driven QA & Compliance

Interpath Laboratory, Inc; Pendleton (OR); Presencial; USD 75.000 - 110.000; Jornada completa

Descripción de la vacante

Interpath Laboratory, Inc. is seeking a Quality Systems Specialist to support QA and regulatory compliance across our clinical laboratory operations in Pendleton, Oregon.

The role combines a clinical laboratory background with expertise in quality systems, regulatory compliance, and continuous improvement. You will administer proficiency testing, monitor QC, maintain documentation, and drive AI-enabled automation to strengthen regulatory readiness.

Formación

• Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, Chemistry, or a related field.
• Minimum of three years of experience in a CLIA-regulated clinical laboratory environment.
• Must qualify for a CLIA non-testing personnel role, such as Technical Consultant, Technical Supervisor, and/or General Supervisor, within one or more clinical laboratory sections (chemistry, hematology, immunology, microbiology, etc.).
• Valid driver's license and clean driving record
• Willingness to learn and use approved AI and automation tools to support quality and compliance work.

Responsabilidades

• Administer proficiency testing programs across regulated analytes and specialties; enrollment, sample distribution, result submission, and post-event review.
• Design and implement automation and process improvements that reduce manual effort while maintaining regulatory compliance.
• Review and analyze PT and quality control data; identify trends and track corrective actions to completion.
• Conduct internal audits against company, regulatory, and accreditation requirements.
• Prepare for and support laboratory inspections conducted by CMS, CAP, state agencies, and other regulatory bodies.
• Investigate lab occurrences, deviations, and nonconforming events; determine root causes and implement CAPA.
• Maintain and improve quality management system documentation; procedures, policies, validation records, training, and indicators.
• Track and analyze quality indicators and prepare leadership dashboards and reports.
• Stay current on CLIA, CAP, FDA, OSHA, HIPAA; translate regulatory changes into operational updates.
• Support method validation and verification activities; review performance data.

Conocimientos

Quality systems

Regulatory compliance

Continuous improvement

AI tools willingness

Educación

Bachelor's degree in Medical Laboratory Science or related

Master's degree in laboratory science or quality

Herramientas

LIS (Laboratory Information Systems)

Document automation tools

Instrumentation interfaces

Descripción del empleo

Interpath Laboratory, Inc. is seeking a Quality Systems Specialist to support QA and regulatory compliance across our clinical laboratory operations in Pendleton, Oregon.

The role combines a clinical laboratory background with expertise in quality systems, regulatory compliance, and continuous improvement. You will administer proficiency testing, monitor QC, maintain documentation, and drive AI-enabled automation to strengthen regulatory readiness.