LabCorp is currently seeking a Clinical Laboratory Quality Manager for Laboratory located at 8490 Upland Hills Drive, Englewood, CO. In this position, the Clinical Laboratory Quality Manager is responsible for the Quality programs, systems, processes and procedures and that the performance and quality of services conform to established regulatory and accreditation requirements within the assigned laboratory or geographic region.

The Clinical Laboratory Quality Manager leads the internal and external audit program and resolution of audit and inspection findings; manages the internal and external proficiency testing program, manages the nonconforming event program and facilities continuous improvement. The Clinical Laboratory Quality Manager also oversees compliance with CLIA, CAP, ISO 15189 and other regulatory and accreditation requirements.

*Must have* clinical testing experience (worked in a CLIA lab, preferably in several lab departments, e.g. Hemo, Chem, micro, ... ). ​

This Quality position is responsible for the Denver Regional laboratory, 4 satellite laboratories and 22 waived laboratories. The main laboratory circumstances require Quality Management to oversee readiness for annual ISO 15189 accreditation audits, clinical trial audits, biennial CAP inspections and occasional CLIA inspections.

Job Duties/Responsibilities:

• Partner with laboratory leadership to develop quality goals and objectives.

• Ensure all laboratories within the assigned area(s) maintain current federal, state and local licensure and accreditations, as applicable.

• Provide guidance for laboratories in implementing policies with respect to regulatory and accreditation requirements.

• Audit laboratories to identify quality issues, nonconformities and opportunities for improvement.

• Formulate responses to accreditation and regulatory citations, nonconforming events and complaints.

• Monitor outcomes of root cause analysis, corrective action and effectiveness checks.

• Facilitate process improvement activities.

• Collect summary data for management reports regarding quality indicators, internal and external audit outcomes, and complaints.

• Provide and ensure training for LabCorp quality policies and procedures.

• Maintain and coordinate communications between laboratories in the assigned area(s), provide assistance where indicated on quality related issues.

Requirements:

• BA/BS degree in Biology, Chemistry, Medical Technology, or related life science. Must meet CLIA regulations.

• **Must have clinical testing experience (has worked in a CLIA lab, preferably in several lab departments, e.g. Hemo, Chem, micro ).

• 5+ years in Quality Assurance and/or Quality Management.

• Previous experience within a clinical diagnostic laboratory setting highly preferred.

Working schedule: 1st shift, Monday-Friday, 8:00am-4:30pm.

Application Window: Closes on September 16th, 2024

Pay Range: $85,000 - $95,000/annual salary

Travel: Potentially 10%

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here (https://careers.labcorp.com/global/en/us-rewards-and-wellness) .

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

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