Clinical Laboratory Scientist

Job Summary The Clinical Laboratory Scientist performs high-complexity testing and provides scientific support to ensure accurate, reliable toxicology results in accordance with CLIA Subpart M, Montana licensure requirements, and accreditation standards (COLA/CAP). The CLS contributes to method verification, quality assessment, corrective actions, and training within the toxicology laboratory. Essential Duties, Responsibilities, and Expectations High-Complexity Testing & Analytical Interpretation (~35%) • Perform, interpret, and validate clinical toxicology assays including LC/MS testing. • Ensure analytic accuracy, precision, and adherence to method performance specifications. Quality Control, Proficiency Testing & Compliance Oversight (~30%) • Review QC, calibration results, maintenance logs, and PT performance. • Implement and document corrective actions for deviations per 42 CFR §493.1281–1289. • Maintain readiness for CLIA inspections and accreditation audits. Method Verification, Validation & Scientific Support (~20%) • Participate in method evaluation studies (accuracy, precision, reportable range). • Assist in reagent lot qualifications and parallel testing studies. Training, Communication & Workflow Coordination (~10%) • Provide technical guidance and training to CLTs and new CLS staff. • Support SOP revision and documentation processes. Other Duties as Assigned (~5%) Minimum Qualifications • Must be legally authorized to work in the United States ; Indigenuity does not sponsor visas. • Bachelor’s degree in laboratory science, medical technology, chemistry, or biology AND four (4) years of high-complexity testing experience ( per 42 CFR §493.1491 ). • Montana CLS licensure (or eligibility). Certificates, Licenses, Registrations • ASCP/AMT certification strongly preferred. Competencies / KSAs • Advanced understanding of analytic chemistry and mass spectrometry. • Strong troubleshooting skills and understanding of QC principles. • Effective communication and documentation skills. • Ability to mentor staff and support scientific decision-making. Physical Demands & Working Conditions • Laboratory environment with biohazard exposure and PPE requirements. • Extended periods of standing and repetitive motion.