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.
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