MANAGER LABORATORY QUALITY (50075519)

HHC • Indianapolis, IN

5d

About The Position

Marion County Public Health Department is an organization that celebrates diversity, and seeks to employ a diverse workforce. We actively encourage all individuals to apply for employment and to seek advancement opportunities. Marion County Public Health Department also provides reasonable accommodations to qualified individuals with disabilities as required by law. For additional questions please contact us at: [e-mail].
Job Role SummaryProvides 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.
Day in the Life
Leads quality audits, reviews laboratory metrics, coordinates regulatory compliance activities, supports laboratory managers, and manages corrective actions to ensure accurate and reliable laboratory testing.

Requirements

• Bachelor’s degree in chemistry, biology, microbiology, medical technology, public health, or related laboratory science
• 5–7 years of laboratory experience in a certified clinical, public health, or environmental laboratory
• Laboratory quality assurance or quality control experience
• MT(ASCP), MLT(ASCP), or equivalent nationally recognized laboratory certification (or equivalent laboratory experience)
• Must meet CLIA requirements for General Supervisor of a high-complexity laboratory (42 CFR 493.1461)
• 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
• Ability to analyze laboratory quality metrics and performance data
• Ability to design quality improvement initiatives and corrective actions
• Ability to conduct regulatory compliance audits
• 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

Nice To Haves

• Master’s degree in laboratory science, microbiology, chemistry, or public health
• Auditing experience and laboratory leadership or supervisory experience
• Certified Quality Auditor (CQA) – American Society for Quality

Responsibilities

• 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.
• 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.
• 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.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level