Manager, Quality Assurance

Labcorp has a Quality Assurance Manager opportunity at the Laboratory in Raliegh, NC. This is a wonderful opportunity to join a strong Quality Team and Exceptional International Organization!

At Labcorp, we are part of the journey to accelerate life-changing healthcare breakthroughs and improve the delivery of care for all. You will be inspired to discover, develop new skills, and pursue career building opportunities as we help solve some of today’s biggest health challenges around the world. Together we embrace possibilities and change lives. We work around the clock and around the world to prove that quality science can solve global health issues and help save individual lives.

Join an exceptional organization and strong Quality department as a Quality Assurance Manager.

Are you knowledgeable about Regulations, Clinical Laboratory Quality Management expereince needed and must have worked in a clinical Laboratory for 7 years with 2 years supervisory expereince? Do you love quality management, problem-solving, and being able to influence and communicate with other laboratory and quality team members?

This Quality Manager will manage the overall quality and regulatory compliance for the Regional Labs. Strong understanding of compliance with CLIA, SAMHSA and DEA regulations, CAP accreditation, and numerous state requirements, including NY, CA, FL, HI, ME, MD, PA, RI, and VT is a MUST.

Apply now!

The 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. 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 facilitates continuous improvement. Oversees compliance with CLIA, CAP, ISO 15189 and other regulatory and accreditation requirements and state requirements.

PRINCIPAL FUNCTIONAL RESPONSIBILITIES

The Quality Manager is responsible for licensure and ensuring compliance with CLIA, SAMHSA and DEA regulations, CAP accreditation, and abundant state requirements, including NY, CA, FL, HI, ME, MD, PA, RI, and VT. The lab undergoes 2x yearly SAMHSA inspections, annual Nuclear Regulatory Commission inspections, and biennial CAP and NY inspections. The Quality Manager also oversees the lab's quality management system, conducts multiple internal audits each year, manages the proficiency testing program, manages the lab's implementation of CAMP for competency assessment and training, reviews method validations, and is responsible for submitting LDTs to NY State for approval and numerous LDTs requiring additional oversight for regulatory compliance.

Quality Assurance:

• Enroll the laboratory in approved proficiency testing programs appropriate for all regulatory agencies for the testing performed. Review results and corrective action.

• Submit proficiency samples for testing; collate data and compile reports for submission to regulatory agencies. Maintain documentation of testing performed and subsequent remedial action if needed.

• Investigate failed assay batches and failed proficiency results with recommendations to laboratory operations regarding corrective actions.

• Establish and maintain quality assurance programs to assure the quality of laboratory services provided and to identify failures in quality as they occur.

• Monitor quality indicators and metrics established by Laboratory Management. Ensure review of Quality Improvement program annually for effectiveness.

• Manage a Quality Analyst and Quality Coordinator.

• Audit the technical activities of the laboratory. Monitor the laboratory to assure laboratory management that equipment, methods, practices, records, controls, and SOPs are in compliance with regulations. Audit the laboratories for compliance with established SOP.

• Provide assistance to laboratory management in preparation for inspections. Prepare and provide all quality assurance information and data for all QA audits and laboratory inspections conducted by regulatory agencies or clients. Interact directly with auditors and inspection teams.

• Provide QA support to all areas that need to evaluate the effectiveness of corrective action implemented and the effectiveness of change made to processes.

• Serve as site administrator for quality management software such as electronic document system and competency assessment system.

• Follow the direction of the Division Quality Director to maintain the overall Quality Management Program of the laboratory. Compile quality assurance summary reports for laboratory quality assurance program.

MINIMUM QUALIFICATIONS

Required Education and Experience:

• Bachelor’s degree in chemical, physical, biological, or clinical laboratory science or medical technology.

• Seven years of related laboratory experience.

• One to two years supervisory experience.

Preferred Education and Experience:

• Additional certifications and specific training preferred (e.g., CQA, CQM/OE, ISO 15189, Six Sigma Black Belt, FDA GLP).

• Regulatory Knowledge and expereince with licensure and ensuring compliance with CLIA, SAMHSA and DEA regulations, CAP accreditation, and state requirements, including NY, CA, and other states.

• Knowledgeable of SAMHSA inspections, annual Nuclear Regulatory Commission inspections, and biennial CAP and NY inspections.

• Knowledgeable of software for competency assessment and training, and reviews method validations.

• Experience submitting LDTs to NY State for approval and has numerous LDTs requiring additional oversight for regulatory compliance.

Other Knowledge, Skills, and Abilities:

• Understand regulations and laws that apply to jobs.

• Able to gather information and utilize resources from varied sources.

• Pay Range: $80,000.00 to $110,000.00/annually

  • 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.

• 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. Employees who are regularly scheduled to work a 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information, please click here .

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging 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 and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), 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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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