QualitySystems Specialist

Interpath Laboratory•Pendleton, OR

31d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.