Job Description
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.
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