Vacancy expired!
Integrated Genetics, part of LabCorp, is seeking a Quality Analyst to join our team in Westborough, MA! The Quality Assurance team provides vital support to the laboratories, senior management as well as our clients, and other LabCorp regional and sister sites.This position will be responsible for supporting management in developing and maintaining pertinent quality documentation for the molecular genetics laboratory. Such tasks include: writing and revising Standard Operating Procedures and Policies, monitoring quality metrics, developing and maintaining training and competency documentation, and assisting with compliance audits. The Quality Analyst allows the laboratory to provide quality results to our providers and patients, which increases customer satisfaction and solidifies loyalty for our company.Responsibilities:Provide leadership in the areas of quality management within the laboratory
Generate reports and compile metrics for quality reviews
Coordinate the review/summary of proficiency results for the molecular laboratory
Participate in improvement opportunities and non-conforming event management
Perform process audits and conduct effectiveness checks
Assess overall compliance with protocols, SOPs, company policies, and applicable regulations
Perform regulatory review of standard operating procedures
Prepare for CAP, and ISO inspections
Participate in regulatory and accrediting agency inspections
Monitor metrics, including root cause analysis and review of corrective action and preventive measures
Support the Quality Management System
Maintain 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 current
Serve as a resource on regulatory issues and compliance
Monitor the progress of implementation and subsequent use of MasterControl document management system
Maintain and coordinate communications between laboratories in the region, providing assistance where indicated on quality assurance related issues
Support the Change Control process
Monitor and respond to other quality assurance issues as assigned
RequirementsNormally requires B.A. /B.S. in Biology, Chemistry, or related scientific discipline
Minimum 2 years of experience assisting with or managing a quality management system in a regulated environment. Previous clinical laboratory highly desired. OR
Minimum 2 years of clinical laboratory experience with experience and familiarity with quality processes
Working knowledge of CLIA regulations and CAP requirements highly desired
Must possess excellent verbal/written communication and presentation skill
Proven expert knowledge of Windows-based software, including Microsoft Word, Access, Excel and Power Point and general knowledge of Visio
Good project management, organizational, written and presentation skills, required
Ability to communicate and build consensus among cross-functional groups
Shift1ScheduleMonday-Friday, 8:30am-5:00pmAs 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.
