Laboratory Quality Assurance Specialist

Interpath Laboratory, Inc; Umatilla (OR); In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

Interpath Laboratory, Inc. is seeking a Quality Systems Specialist to support QA and regulatory compliance across clinical operations, leveraging a laboratory background with quality systems expertise.

The role administers proficiency testing, implements automation, conducts internal audits, and coordinates CMS/CAP/state inspections, with a focus on AI-enabled quality improvements. On-site in Pendleton, Oregon, Monday–Friday with occasional extended hours and travel to other Interpath locations

Competenze

• Bachelor's degree in a lab science field and 3+ years in a CLIA-regulated lab.
• Qualified for a CLIA non-testing personnel role in a lab section.
• Valid driver's license and clean driving record.
• Willingness to learn and use AI/automation tools.
• Master's degree preferred.

Mansioni

• Administer proficiency testing programs across regulated analytes.
• Design automation to reduce manual work while maintaining compliance.
• Review PT and QC data to identify trends and drive corrective actions.
• Conduct internal audits against regulatory and accreditation requirements.
• Prepare for CMS/CAP/state inspections.
• Investigate deviations and implement corrective actions.
• Maintain quality management system documentation.
• Analyze quality indicators and prepare leadership dashboards.
• Stay current on CLIA, CAP, FDA, OSHA, HIPAA requirements.

Conoscenze

Quality systems

Regulatory knowledge

Process improvement

AI tools

Data analysis

Formazione

Bachelor's degree in Medical Laboratory Science

Master's degree in related field

Strumenti

LIS experience

Middleware

Instrument interfaces

Descrizione del lavoro

We’re looking for a Quality Systems Specialist to support quality assurance and regulatory compliance across our clinical laboratory operations. This role combines a clinical laboratory background with expertise in quality systems, regulatory compliance, and continuous improvement.

The Quality Systems Specialist independently administers and improves quality assurance programs supporting Interpath Laboratory's headquarters laboratories. This role manages proficiency testing, monitors quality control performance, maintains required quality documentation, and supports compliance with CLIA, CAP, state, and other applicable regulatory requirements.

The position works closely with laboratory leadership, technical staff, IT, and clinical systems teams to identify quality risks, investigate nonconforming events, implement corrective actions, and improve laboratory processes. This role also champions the use of artificial intelligence and automation to reduce manual effort, improve accuracy, and strengthen regulatory readiness.

Location & Schedule

• Schedule: Monday–Friday, standard business hours, with occasional extended hours to support regulatory deadlines, audits, or inspections.
• Location: On-site in Pendleton, Oregon.
• Travel: Occasional travel to other Interpath Laboratory locations is required.

Minimum 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, such as Technical Consultant, Technical Supervisor, and/or General Supervisor, within one or more clinical laboratory sections (i.e. chemistry, hematology, immunology, microbiology, etc.).
• Valid driver's license and clean driving record.
• Willingness to learn and use approved A.I. and automation tools to support quality and compliance work.

Preferred Qualifications

• Master's degree in laboratory science, quality, healthcare administration, or a related field.
• Two or more years of experience in laboratory quality assurance, regulatory compliance, proficiency testing, or accreditation activities.
• Experience using AI tools, large language models, document automation, or data analysis platforms to improve workflows, documentation, or analytics.
• Experience supporting or leading laboratory inspections or accreditation surveys.
• Experience with laboratory information systems (LIS), middleware, or instrument interfaces.
• Experience with method validation, verification, and statistical QC tools, including Levey-Jennings charts, Westgard rules, or Six Sigma metrics.
• ASCP or equivalent certification as MLS, MLT, CLS, or another recognized laboratory credential.
• Laboratory quality certification, such as ASQ CQA or equivalent.

What You’ll Do

• 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.

Work Environment & Physical Requirements

• Prolonged periods of sitting, standing, walking, and working at a computer.
• Close visual work, including reading laboratory documentation, instrument displays, and computer screens.
• Potential exposure to biological specimens, chemical reagents, and laboratory instrumentation.
• Required use of personal protective equipment and adherence to laboratory safety policies when working in laboratory areas.
• Ability to occasionally lift, carry, push, or pull up to 25 pounds.
• Ability to travel occasionally to other Interpath Laboratory locations.

About Us

Interpath Laboratory is a family-owned and operated clinical and anatomic pathology laboratory serving communities across Oregon, Washington, Nebraska, and Idaho. With more than 90 locations and over 60 years of steady growth, we are one of the Pacific Northwest’s leading independent laboratories, with plans for continued and strategic expansion into the Midwest.

We are known for delivering rapid, reliable, and cost-effective laboratory testing while maintaining the flexibility, innovation, and personal connection that come from remaining independent. Our success is built on strong relationships—with our clients, our patients, and most importantly, our employees.

At Interpath, we foster a collaborative, supportive work environment where teamwork, professionalism, and positive attitudes matter. We believe great results start with great people, and we are committed to creating a workplace where employees can build meaningful careers while making a real impact in the communities we serve.

We are excited to share with you a short video that shows why the Interpath family is so special.