AI-Driven Quality Systems Specialist - Lab Compliance

interpath; Pendleton (OR); On-site; USD 85,000 - 115,000; Full time

Job summary

Interpath Laboratory seeks a Quality Systems Specialist to support QA and regulatory compliance across our clinical laboratory operations. This role blends a clinical laboratory background with quality systems, regulatory knowledge, and continuous improvement.

The Quality Systems Specialist independently administers and improves QA programs, manages proficiency testing, monitors QC performance, and ensures CLIA, CAP, and state compliance while collaborating with leadership, IT, and clinical

Qualifications

• Bachelor's degree in MLS/CLS/biology/chemistry or related field.
• Minimum 3 years in CLIA-regulated clinical laboratory.
• Qualified for CLIA non-testing personnel role (Technical Consultant/Supervisor) in one or more CLIA sections.
• Valid driver's license and clean driving record.
• Willingness to use AI and automation tools.

Responsibilities

• Administer proficiency testing programs across regulated analytes and specialties.
• Design automation and process improvements that reduce manual effort while maintaining regulatory compliance.
• Review PT and QC data, identify trends, and track corrective and preventive actions to completion.
• Conduct internal audits against 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 actions.
• Maintain and improve quality management system documentation, including procedures, policies, validation records, competency assessments, training records, and quality indicators.
• Track and analyze key laboratory quality indicators and prepare dashboards and reports for leadership.
• Maintain current knowledge of CLIA, CAP, FDA, OSHA, HIPAA, state, and other applicable laboratory requirements and translate regulatory changes into operational updates.
• Support method validation and verification activities, including reviewing performance data and documentation.
• Use approved AI resources and automation platforms to improve quality documentation, analyze QC and PT data, identify compliance risks, and strengthen quality workflows.
• Identify opportunities to automate document control, competency tracking, inspection preparation, regulatory monitoring, and corrective action processes.
• Collaborate with laboratory leadership, technical supervisors, IT, and clinical systems staff to support quality and compliance objectives.
• Train and coach laboratory staff on quality requirements, regulatory updates, procedures, and quality system tools.

Skills

Quality assurance

Regulatory compliance

Proficiency testing

Auditing

Process improvement

AI tools experience

Data analysis

Education

Bachelor's degree in Medical Laboratory Science / Clinical Laboratory Science / Biology / Chemistry

Master's degree in laboratory science / quality / healthcare administration

Tools

Laboratory Information Systems (LIS)

Middleware

Automation platforms

Documentation automation tools

Statistical QC tools

Job description

Interpath Laboratory seeks a Quality Systems Specialist to support QA and regulatory compliance across our clinical laboratory operations. This role blends a clinical laboratory background with quality systems, regulatory knowledge, and continuous improvement.

The Quality Systems Specialist independently administers and improves QA programs, manages proficiency testing, monitors QC performance, and ensures CLIA, CAP, and state compliance while collaborating with leadership, IT, and clinical