Labcorp · 9 hours ago
Quality Auditor
Labcorp is seeking a Laboratory Quality Auditor to join our team in St. Paul, MN. The Quality Auditor will be responsible for supporting projects and activities related to quality assurance, quality improvement, quality training, and ensuring compliance with regulations and accreditation requirements.
BiotechnologyHealth CareHospitalLife ScienceMedicalPrecision Medicine
Responsibilities
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
Qualification
Required
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)
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
Preferred
Prior experience in a clinical laboratory is highly preferred
Familiarity with an electronic data management system is a plus (i.e. MasterControl)
Benefits
Medical
Dental
Vision
Life
STD/LTD
401(k)
Paid Time Off (PTO) or Flexible Time Off (FTO)
Tuition Reimbursement
Employee Stock Purchase Plan
Company
Labcorp
Labcorp specializes in providing physicians with laboratory tests.
H1B Sponsorship
Labcorp has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$2.85B2024-09-16Post Ipo Debt· $2B
2019-06-04Post Ipo Debt· $850M
1988-07-15IPO
Leadership Team
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