The Laboratory Manager provides combined technical, scientific, and operational supervision for Indigenuity Clinical Laboratory Inc., a CLIA-certified high-complexity toxicology reference laboratory. This role fulfills the Technical Supervisor responsibilities under 42 CFR §493.1461–1463 and the General Supervisor responsibilities under 42 CFR §493.1469–1471.
Requirements
Essential Duties, Responsibilities, and Expectations
Technical & Scientific Oversight (~35%)
- Establishes and verifies performance specifications (accuracy, precision, analytical sensitivity/specificity, reportable range).
- Ensures reliable operation of LC/MS and other high-complexity systems.
- Reviews and interprets QC, maintenance logs, and performance trends.
- Oversees method validation, assay improvements, and instrument optimization.
Regulatory Compliance, Quality System Oversight & Proficiency Testing (~30%)
Ensures compliance with CLIA, CMS, Montana laboratory licensure, OSHA, and accrediting bodies (CAP or COLA).
- Maintains inspection readiness; oversees regulatory documentation and corrective actions.
- Ensures PT enrollment, evaluates PT performance, and implements required corrective measures.
- Ensures SOPs are accurate, up-to-date, reviewed annually, and followed consistently.
- Oversees reagent lot validations, calibrations, and quality assurance studies.
Personnel Supervision, Competency & Training (~20%)
- Conducts competency assessments per CLIA requirements (initial, 6-month, 12-month, and annually).
- Provides staff training on analytic systems, QC, troubleshooting, and SOPs.
- Evaluates employee performance and identifies professional development needs.
- Ensures adherence to safety and compliance protocols.
Operational Management & Workflow Coordination (~10%)
- Coordinates equipment service, supply management, and vendor relations.
- Assists with scheduling, coverage planning, and resource allocation.
- Supports LIS integration, data integrity, and documentation standards.
Other Duties as Assigned (~5%)
- Assists the Laboratory Director with audits, investigations, and special projects.
- Participates in meetings and consultative discussions with internal/external stakeholders.
Minimum Qualifications
Candidate must be legally authorized to work in the United States.
- Indigenuity Clinical Laboratory Inc. does not sponsor visas.
- Montana licensure required as applicable.
Must meet one of the qualification pathways for Technical Supervisor per 42 CFR §493.1461, such as:
- Master’s degree in a related science + 2 years high-complexity experience; OR
- Bachelor’s degree in a related science + 4 years high-complexity laboratory experience.
- Experience must include high-complexity toxicology, preferably with LC/MS.
Preferred Experience
- Experience in method validation, quality systems, and regulatory compliance.
- Experience with LC/MS maintenance, troubleshooting, and assay development.
Licensure / Certification
- ASCP, AMT, or equivalent preferred.
Competencies / Knowledge, Skills, and Abilities (KSAs)
Technical Competencies
- Expertise in method validation, accuracy/precision studies, and QC evaluation.
- Ability to analyze complex technical data and performance trends.
Regulatory & Compliance Competencies
- Ability to maintain inspection readiness and manage regulatory documentation.
Supervisory & Operational Competencies
- Effective leadership and communication skills.
- Ability to train, mentor, and evaluate staff.
- Strong organizational and workflow management abilities.
Behavioral Competencies
- Cultural competence and contribution to a supportive workplace culture.
- Routine exposure to chemicals and biohazards; PPE required.
- Standing, pipetting, instrument operation, and repetitive tasks required.
- Lifting up to 25 pounds occasionally.
NADC/Indigenuity Clinical Lab Inc. is an Equal Opportunity Employer. Employment decisions are made based on qualifications, merit, and organizational needs, without regard to race, religion, color, sex, gender identity, sexual orientation, age, disability, or national origin.
Benefits
- Healthcare
- Retirement
- Dental
- Mental Health
Skills Required
- Legally authorized to work in the United States
- Employer does not sponsor visas
- Montana licensure as applicable (Clinical Laboratory Scientist license or eligibility)
- Meet CLIA Technical Supervisor qualification pathway (Doctoral +1 year OR Master's +2 years OR Bachelor's +4 years of high-complexity experience)
- Experience with high-complexity toxicology testing, preferably with LC/MS
- Supervisory or management experience in a clinical laboratory
- Experience in method validation, quality systems, and regulatory compliance (CLIA/CMS/OSHA, CAP or COLA)
- ASCP, AMT, or equivalent certification
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