Specialist, Quality Assurance
Quest Diagnostics - Indianapolis, IN
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Support and coordinate efforts that foster quality and ensure that all pre-analytical,analyticaland post-analytical processes are consistent with our company values and mission.Licensing and AccreditationSupport the internal inspection process of the business unit, associatedlaboratoriesand specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and Quest Diagnostics standards.Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards.Proficiency TestingAssist and ensure enrollment and participation in proficiency testing for each test to include Corrective Action when necessary.Coordinate the Validity Check program and Blind Samplesresubmission program, if applicable.Assist in maintaining a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process.Quality Assurance/QualityImprovement Support and assist on monthly Quality Assurance (QA) meetings. Support each department's comprehensive Quality Improvement (QI) plan. Assist in maintaining and monitoring Quality Assurance specific quality indicators.Facilitate the preparation,distributionand review of the QA Manual.Support the Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes VerificationProgramand other monitoring programs specifically assigned by National Quality Assurance. Quality Assurance InitiativesAssist in the prompt and complete reporting of Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP).Assist in the complete tracking of revised reports in compliance with the SOP.Assist in any other duties as assigned by the Technical Manager.Required WorkExperience:At least three years employment in a laboratory setting preferredExperience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirementsrequired.Preferred Work Experience:Previous experience with Quality Assurance.Physical and Mental Requirements:The normal performance of duties may require lifting and carrying objects: Objects 1 to 10 pounds are lifted and carried frequently; objects 11 to 25 pounds are lifted and carried occasionally; objects 36 to 50 pounds are seldom lifted or carried and objects over 50 pounds are not to be lifted or carried without assistance.Ability to sit or stand for long periods of time.Knowledge:Knowledge of CAP, CLIA, GLP and ISO standards and regulations.Basic theoretical and operational job knowledge in quality assurance and laboratory operations.Knowledge of organizational/departmental policies and procedures.Demonstrates knowledge of current company policies and procedures.Knowledge of CAP, CLIA, GLP and ISO standards and regulations.Demonstrates knowledge of current local, state, and federal requirements.Demonstrates initiative and strong problem-solving skills, teamwork, and interdepartmental collaboration.Skills:Strong interpersonal communication skillsrequiredDemonstrated strong writing and composition skillsrequiredUnderstands clinical laboratory operationsrequiredAble to effect Quality Improvement through problem solving skills and knowledge of quality tools requiredAble to manage changerequired Organization skillsrequired Project management skills requiredAnalytical skills requiredTechnical skills requiredComputer skills requiredAble to function in a matrix organization desirableMulti-tasking skills desirableDemonstrated success in motivating team members to reach objectivesdesirableEDUCATION Associate degree w/ min. 3 years QA related experience. Bachelor's Degree Preferred.Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets
Created: 2024-10-03