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Manager Laboratory Quality

Provides leadership and oversight for the laboratory quality management system supporting clinical and environmental laboratory services. Ensures compliance with regulatory and accreditation requirements while maintaining effective quality assurance, quality control, and continuous improvement systems.

Essential Duties

Quality Management & Compliance — 50%

• Lead and maintain the laboratory quality management system across clinical and environmental laboratories.
• Interpret and apply regulatory and accreditation requirements, including CLIA, AIHA, EPA, FDA, and CDC standards.
• Develop and maintain laboratory quality assurance and quality control programs covering pre-analytical, analytical, and post-analytical testing phases.
• Monitor compliance through internal audits, regulatory preparation, and quality system reviews.
• Track and analyze laboratory quality metrics and performance indicators.

Laboratory Auditing & Quality Improvement — 30%

• Conduct internal audits of laboratory disciplines, including chemistry, microbiology, and immunology.
• Investigate quality issues, including proficiency testing failures, QC excursions, and audit findings.
• Implement corrective and preventive actions and evaluate effectiveness.
• Manage client complaints and coordinate resolution with laboratory leadership.
• Lead quality improvement initiatives and process improvement projects.

Regulatory Oversight & Technical Consultation — 20%

• Serve as CLIA Technical Consultant and regulatory liaison for laboratory certification and accreditation activities.
• Coordinate regulatory inspections, accreditation applications, and compliance reporting.
• Provide technical guidance on laboratory testing standards and procedures.
• Support validation, implementation, and evaluation of new laboratory testing methods.

Associated Job Duties

• Serve in CLIA supervisory roles when required, including General Supervisor or Technical Supervisor responsibilities in the absence of laboratory leadership.
• Assist in evaluating competency of laboratory testing personnel and ensuring compliance with laboratory standards.
• Develop and deliver training related to laboratory quality systems and compliance requirements.
• Participate in public health emergency preparedness exercises and in the response to public health emergencies, as directed.
• Participate in a minimum of two H.O.P.E. events totaling at least eight (8) hours annually.
• This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. The employee may be asked to perform other duties as needed to support departmental and organizational goals.

Qualifications

Education

Required: Bachelor's degree in chemistry, biology, microbiology, medical technology, public health, or related laboratory science

Preferred: Master's degree in laboratory science, microbiology, chemistry, or public health

Experience

Required: 5–7 years of laboratory experience in a certified clinical, public health, or environmental laboratory

Required: Laboratory quality assurance or quality control experience

Preferred: Auditing experience and laboratory leadership or supervisory experience

Licenses/Certifications Required

Required: MT(ASCP), MLT(ASCP), or equivalent nationally recognized laboratory certification (or equivalent laboratory experience)

Required: Must meet CLIA requirements for General Supervisor of a high-complexity laboratory (42 CFR 493.1461)

Preferred (obtain within 2 years): Certified Quality Auditor (CQA) – American Society for Quality

Knowledge, Skills & Abilities

Laboratory Science & Regulations

• Knowledge of microbiology, chemistry, and immunology laboratory practices
• Knowledge of CLIA, AIHA, EPA, FDA, CDC, and OSHA regulatory standards
• Knowledge of laboratory quality management and auditing principles

Analytical & Quality Management Skills

• Ability to analyze laboratory quality metrics and performance data
• Ability to design quality improvement initiatives and corrective actions
• Ability to conduct regulatory compliance audits

Communication & Technical Leadership

• Ability to communicate technical information clearly to laboratory staff and leadership
• Ability to develop policies, procedures, and training materials
• Proficiency with laboratory information systems and Microsoft Office applications

Contacts – Internal/External

Internal: Laboratory leadership, clinical laboratory staff, environmental laboratory staff, MCPHD leadership

External: Regulatory and accreditation agencies, including CLIA, AIHA, EPA, CDC, FDA, and public health partners

Working Environment

Other program hazards the position may encounter:

• Bloodborne Pathogens
• Hazardous Material Handling
• Work performed in clinical, environmental chemistry, microbiology, and BSL-2 / BSL-3 laboratory environments
• Possible exposure to biological and chemical hazards
• May require standing or walking for extended periods
• May require lifting up to 40 pounds

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Nearest Major Market: Indianapolis