Laboratory Corporation of America Clinical Lab Quality Analyst in Burlington, North Carolina
Laboratory Corporation of America Holdings (NYSE:LH), an S&P 500 company is a leading life sciences company, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster and uses technology to provide better care. With net revenue in excess of $9 billion in 2016, LabCorp's 50,000 employees serve clients in 60 countries.
LabCorp is seeking a Quality Analyst to join our Toxicology department. The Toxicology Department at the Center for Esoteric Testing in Burlington, NC is a part of our specialty testing group. It's composed of four separate sections: Biological Monitoring, Therapeutic Drug monitoring, Megaloblastic Anemia Profile, Pain Management/Treatment Center Drug Screens, and Mass Spectrometry/Esoteric Testing.
This position will be responsible coordinating the efforts of the regional staff to maintain LabCorp's quality assurance program at all testing departments.
Leads quality and regulatory strategy; oversees the creation, execution, and maintenance of the quality management system policies and procedures; and manages the day-to-day activities of the quality department.
Coordinates and tracks external and internal proficiency testing
Tracks and documents various reports and provides documentation to Division.
Keeps abreast of new or revised applicable international, national, state, and local requirements for licensing, certifying, and accrediting agencies. Communicates information clearly, succinctly, and in a timely manner throughout the facility.
Assists with identifying, remediating, and documenting quality issues per established protocols.
Oversees the internal audit program and participates as an auditor.
Responsible for review of findings, responses to external auditing agencies, and evaluation of the effectiveness of corrective actions.
Prepares monthly reports for senior operations leadership for management reviews.
Other duties as assigned by management
Must have a BA/BS degree preferably in Biology, Chemistry, Medical Technology, or other related science.
2-5 years of clinical laboratory experience
Clinical quality management experience highly desired
Strong knowledge of CAP, NYS, CLIA and ISO 15189 standards preferred
Strong knowledge of root cause analysis and risk assessment process
Experience as an internal or external auditor
Proven experience as a meeting facilitator
Proficient in Microsoft Office Suite
Ability to manage multiple projects independently or as part of a team
Must possess excellent verbal/written communication and presentation skills
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.