Quality Systems Specialist - AI & Automation for Compliance

Interpath Laboratory, Inc; Pasco (WA); On-site; USD 85,000 - 125,000; Full time

Job summary

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

The position independently administers and improves QA programs across Interpath Laboratory's headquarters laboratories, managing proficiency testing, QC monitoring, documentation, and compliance with CLIA, CAP, and state

Qualifications

• Bachelor's degree in a relevant science field and clinical lab experience.
• 3+ years in a CLIA-regulated lab environment.
• Willingness to learn AI and automation tools.

Responsibilities

• Administer proficiency testing (PT) programs across regulated analytes and specialties, including 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 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.
• 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.
• Maintain confidentiality of patient, laboratory, employee, and proprietary information.
• Maintain consistent, reliable attendance.
• Perform related duties as required and additional duties as the needs of the position evolve.

Skills

Quality assurance

Regulatory knowledge

AI tooling readiness

Education

Bachelor's in MLS

Tools

LIS software

Document automation

Six Sigma tools

QA automation

Job description

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

The position independently administers and improves QA programs across Interpath Laboratory's headquarters laboratories, managing proficiency testing, QC monitoring, documentation, and compliance with CLIA, CAP, and state