The Quality Assurance Analyst will provide leadership in the areas of quality assurance, quality-related training and standardization within the laboratory. This position will also be responsible for project management activities to improve the quality and/or efficiency of laboratory operations. This position allows CMBP to provide quality results to our providers and patients.
The schedule for this position is Monday-Friday between 8am-4:30pm.
Responsibilities:
Coordinates the review/summary of proficiency results for ten laboratories within CMBPParticipates in improvement opportunities and non-conforming event management throughout CMBPPerforms process audits and conducts effectiveness checksAssess overall compliance with protocols, SOPs, company policies, and applicable regulationsPerforms regulatory review of standard operating proceduresParticipates in regulatory and accrediting agency inspectionsMonitors metrics, including root cause analysis and review of corrective action and preventive measuresSupports the Quality Management SystemMaintains knowledge of federal state and local requirements of certifying and accrediting agencies, i.e. CMS, CAP, ISO15189 and New York State, by reviewing regulations publications and other resources necessary to remain currentServes as a resource on regulatory issues and complianceMonitors the progress of implementation and subsequent use of MasterControl document management systemProvides continuing education programs for staff development in the areas of quality control, quality assurance, CLIA regulations and LabCorp policiesMaintains and coordinates communications between laboratories in the region, providing assistance where indicated on quality assurance related issuesSupports Clinical Trial activities (providing documentation for auditors)Supports the Change Control processProvides support activities for all CMBP departmentsMonitors and responds to other quality assurance issues as assigned
Requirements:
B.A./B.S. in Biology, Chemistry, Medical Technology or related life science required.Working knowledge of CLIA regulations and CAP requirements required.Travel once a quarter to Greenville, NC is required to audit one of our sister sites.Two years of clinical laboratory experience is preferred.Two years of managing or assisting in managing the quality management system in a clinical laboratory is preferred.Prior auditor experience is strongly preferred.Must possess excellent verbal/written communication and presentation skills.Proven expert knowledge of Windows-based software, including Microsoft Word, Access, Excel and Power Point and general knowledge of Vision.Good project management, organizational, written and presentation skills, required.Ability to communicate and build consensus among cross-functional groups.
Our U.S. Personal Choice Benefits
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Benefits: 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. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable. For more detailed information, please click here.
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