Quality Systems Specialist - Lab Compliance & AI Innovation

Interpath Laboratory, Inc; Richland (WA); Sur place; USD 95 000 - 125 000; Plein temps

Résumé du poste

Interpath Laboratory is seeking a Quality Systems Specialist to support QA and regulatory compliance across clinical laboratory operations. This role combines a clinical laboratory background with expertise in quality systems, regulatory compliance, and continuous improvement.

The position collaborates with laboratory leadership, IT, and clinical systems teams to identify quality risks, investigate nonconforming events, implement corrective actions, and improve processes, while championing AI

Qualifications

• Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, Chemistry, or a closely related scientific discipline.
• Minimum of three years of experience in a CLIA-regulated clinical laboratory environment.
• Must qualify for a CLIA non-testing personnel role within one or more clinical laboratory sections.

Responsabilités

• Administer proficiency testing (PT) programs across regulated analytes and specialties.
• 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 out-of-control conditions, and track corrective and preventive 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 or accrediting organizations.
• Investigate laboratory occurrences, deviations, complaints, and nonconforming events; evaluate evidence, determine root causes, and implement corrective and preventive actions.

Connaissances

Quality assurance

Regulatory compliance

Continuous improvement

Proficiency testing

Documentation accuracy

Formation

Bachelor's degree in Medical Laboratory Science or related field

Master's degree in laboratory science or quality (preferred)

Outils

LIS

Middleware

Instrument interfaces

AI tools experience

Document automation

Data analysis platforms

Description du poste

Interpath Laboratory is seeking a Quality Systems Specialist to support QA and regulatory compliance across clinical laboratory operations. This role combines a clinical laboratory background with expertise in quality systems, regulatory compliance, and continuous improvement.

The position collaborates with laboratory leadership, IT, and clinical systems teams to identify quality risks, investigate nonconforming events, implement corrective actions, and improve processes, while championing AI