Clinical Laboratory Quality Manager

2 weeks ago

South Bend, United States Labcorp Full time

LabCorp is currently seeking a Clinical Laboratory Quality Manager 

In this position, the Clinical Laboratory Quality Manager is responsible for the Quality programs, systems, processes and procedures conform to established regulatory and accreditation requirements within the assigned laboratory or geographic region. This position is in the laboratory and following training it can be a Hybrid role.

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. 

The Quality Manager manages the Quality programs, systems, processes, and procedures to conform to established regulatory and accreditation requirements within the assigned laboratory or geographic region. This position leads the internal and external audit program, including resolution of audits, and inspection findings. The position is responsible to manage the internal and external proficiency testing program, the nonconforming event program, and to facilitate continuous improvement. The Quality Manager will oversee compliance with CLIA, CAP, ISO 15189, and other regulatory and accreditation requirements.

PRINCIPAL FUNCTIONAL RESPONSIBILITIES:

  • Promote a culture of quality.

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

  • Develop positive and supportive working relationships with laboratory management and staff in the assigned areas.

  • Ensure all laboratories within the assigned areas maintain current federal, state, and local licensure and accreditations, as applicable. Always keeping a regulatory readiness.

  • 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.

  • Oversight of proficiency testing program.

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

  • Provide education to laboratory staff in root cause analysis and investigation of non-conforming events.

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

  • Facilitate process improvement activities.

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

  • Participate and/or lead in Quality meetings, process improvement teams and regulatory initiatives.

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

  • Maintain and coordinate communications between laboratories in the assigned areas, aid when indicated on quality related issues.

  • Must provide excellent communication with the Divisional Quality Director.

  • Must function in a team environment and adhere to labcorp policy and processes.

  • Must have a dedicated home office to perform job duties in a secure and consistent manner.

  • Approximately 20% travel to laboratories.

Additional

  • This Quality Professional will regionally travel up to 20% as needed.

  • Mobile phone is provided.

Education / Qualification(s)

  • B.S. in Laboratory Science (or related field)

  • 4-5 years of Clinical Laboratory experience

Why People choose to work at Labcorp?

At Labcorp, it’s our people that make us great – it’s what our clients, our partners and, most importantly, what our employees say. Here, you’ll have the opportunity to work with extraordinary people with diverse viewpoints. You’ll discover your own outstanding potential as we build an even stronger organization with industry leaders from early development to the clinic and beyond.  We help our clients develop medicines that improve health and improve lives of their family and friends.

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.  Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here . 

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.

We encourage all to apply

If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site  or contact us at Labcorp Accessibility .

For more information about how we collect and store your personal data, please see our Privacy Statement .

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