Quality Auditor

Labcorp is seeking a Laboratory Quality Auditor to join our team in St. Paul, MN. The Quality Assurance team provides vital support to the laboratories, senior management as well as our clients, and other Labcorp sites. The Quality Auditor will be responsible for supporting projects and activities related to quality assurance, quality improvement, quality training, and other responsibilities of the Quality Assurance department. The Quality Auditor allows the laboratory to provide quality results to our providers and patients, which increases customer satisfaction and solidifies loyalty for our company.

**Pay Range: $72,000 - $88,000 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.

Work Schedule: Monday - Friday, dayshift

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.

• Maintain competency and understanding of quality requirements for laboratory accreditation agencies, including CAP/CLIA, SAMHSA, NYSDOH, and others
• Plan and conduct the internal audits of the technical activities of the Clinical and Forensic Laboratories
• Monitor the laboratory to assure laboratory management that equipment, methods, practices, records, controls, SOPs and policies are in compliance with regulations and accreditation requirements
• Monitor/audit the performance of critical/key laboratory vendors, as needed
• Plan and conduct internal audits of administrative departments, including IT/LIS, Facilities/Biomed, etc. to assure management that practices, records, controls, and SOPs are in compliance with regulations and accreditation requirements
• Report all findings to management through internal audit reports
• Follow-up on corrective/remedial actions to assure appropriate actions were taken and were effective
• Aid directors, managers, and supervisory personnel in preparing for inspections. Actively participate in all external inspections and audits, as directed
• Follow the direction of the Division Quality Director to maintain the overall Quality Management System

• Bachelors degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements
• 5 years of previous experience as a Medical Technologist/Technician or in a quality related position
• ASQ Certified Quality Auditor (CQA) or equivalent certification is required or must be obtained within first 12 months. Additional certifications and specific training may be required depending upon primary responsibility (e.g., RQAP-GLP, CMQ/OE, ISO, FDA GxP)
• Prior experience in a clinical laboratory is highly preferred
• Familiarity with an electronic data management system is a plus (i.e. MasterControl)
• General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements
• Strong understanding of audit related requirements and procedures
• Working knowledge of quality assurance/quality management best practices
• Excellent analytical, critical thinking and problem solving skills
• Strong communication skills; both written and verbal
• High level of attention to detail with strong organizational skills
• Ability to work independently and within a team environment
• Strong computer skills with proficiency with MS Office programs