Native American Development Corporation
Laboratory Manager (Technical & General Supervisor TS/GS)
Native American Development Corporation, Billings, Montana, us, 59107
Job Summary
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.
The Laboratory Manager ensures accurate testing performance, oversees method validation, maintains regulatory compliance, supervises personnel, conducts competency evaluations, manages workflow, and supports quality and accreditation requirements.
This position plays a critical leadership role to ensure reliable, compliant, and high-quality toxicology services that support patient care and organizational goals.
Essential Duties, Responsibilities, and Expectations Technical & Scientific Oversight (~35%)
Selects, evaluates, and approves test methodologies appropriate for clinical toxicology.
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%)
Supervises CLS and CLT staff, ensuring appropriate delegation and task assignment.
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%)
Manages daily workflow to ensure turnaround time (TAT) expectations are met.
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.
Required Education & Experience (CLIA Technical Supervisor Requirements) Must meet one of the qualification pathways for Technical Supervisor per 42 CFR §493.1461, such as:
Doctoral degree in chemical, physical, biological, or clinical laboratory science + 1 year of high-complexity experience; OR
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
Supervisory or management experience in a clinical laboratory setting.
Experience in method validation, quality systems, and regulatory compliance.
Experience with LC/MS maintenance, troubleshooting, and assay development.
Licensure / Certification
Montana Clinical Laboratory Scientist license (or eligibility), if required by state law.
ASCP, AMT, or equivalent preferred.
Competencies / Knowledge, Skills, and Abilities (KSAs) Technical Competencies
Advanced knowledge of LC/MS systems and toxicology assay workflows.
Expertise in method validation, accuracy/precision studies, and QC evaluation.
Ability to analyze complex technical data and performance trends.
Regulatory & Compliance Competencies
Strong understanding of CLIA, CMS, OSHA, HIPAA, and accreditation requirements.
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
Professionalism, accountability, and attention to detail.
Cultural competence and contribution to a supportive workplace culture.
Physical Demands & Working Conditions
Work performed in a clinical laboratory environment.
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.
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The Laboratory Manager ensures accurate testing performance, oversees method validation, maintains regulatory compliance, supervises personnel, conducts competency evaluations, manages workflow, and supports quality and accreditation requirements.
This position plays a critical leadership role to ensure reliable, compliant, and high-quality toxicology services that support patient care and organizational goals.
Essential Duties, Responsibilities, and Expectations Technical & Scientific Oversight (~35%)
Selects, evaluates, and approves test methodologies appropriate for clinical toxicology.
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%)
Supervises CLS and CLT staff, ensuring appropriate delegation and task assignment.
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%)
Manages daily workflow to ensure turnaround time (TAT) expectations are met.
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.
Required Education & Experience (CLIA Technical Supervisor Requirements) Must meet one of the qualification pathways for Technical Supervisor per 42 CFR §493.1461, such as:
Doctoral degree in chemical, physical, biological, or clinical laboratory science + 1 year of high-complexity experience; OR
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
Supervisory or management experience in a clinical laboratory setting.
Experience in method validation, quality systems, and regulatory compliance.
Experience with LC/MS maintenance, troubleshooting, and assay development.
Licensure / Certification
Montana Clinical Laboratory Scientist license (or eligibility), if required by state law.
ASCP, AMT, or equivalent preferred.
Competencies / Knowledge, Skills, and Abilities (KSAs) Technical Competencies
Advanced knowledge of LC/MS systems and toxicology assay workflows.
Expertise in method validation, accuracy/precision studies, and QC evaluation.
Ability to analyze complex technical data and performance trends.
Regulatory & Compliance Competencies
Strong understanding of CLIA, CMS, OSHA, HIPAA, and accreditation requirements.
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
Professionalism, accountability, and attention to detail.
Cultural competence and contribution to a supportive workplace culture.
Physical Demands & Working Conditions
Work performed in a clinical laboratory environment.
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.
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