Specialist, Quality Assurance

Job TitleSpecialist, Quality Assurance, Compliance & SafetyResponsibilitiesThe Specialist, Quality Assurance, Compliance & Safety position is intended to provide oversight and support for the Quality Program-Quality Management Planning, inspection preparedness and responses associated with laboratory accreditation, non-conformance management and Document Control management, and training and competency monitoring.Quality Assurance:Work with the Laboratory Director and Department Supervisors to facilitate the Quality Management Planning process.Identify and monitor quality indicators.Schedule and conduct Quality Meetings and distribute the minutes.Ensure inspection preparedness by conducting internal audits of laboratory processes to identify non-conformances and areas of needed improvement.Appropriate Authorization, Delegations, and associated Performance AssessmentsTraining and Competency documented via MediaLab.Testing ExceptionsEffectively create and complete Corrective and Preventive Actions (CAPAs) for areas where non-conformances are identified.Immediate Corrective ActionsPreventative Actions with Patient RemediationContinuous monitoring and Effectiveness ChecksLicense Coordinator for accreditation licensure.QA Record organization and adherence to record retention requirements.Responsible for management of the CAP website as applicable for the organizational profile as well as testing and supervisory personnel.SmartSolve Software Administration for Document Control.Manage SOP Life Cycle (Implementations, Recurring Reviews, Administrator monitoring reports).Quality metrics data collection and analysis to identify trends and needed interventions.Other duties as assigned.SafetyAssists in safety audits, inspections, internal and external regulatory activities.Assists with monthly safety meetings, SDS, JHA'sFacilitate in ensuring safe environment is maintainedEnsures corporate safety protocols are followedEnsures Safety is part of the Quality Management PlanComplianceAssist in monitoring privacy incidents in RadarEnsures corporate compliance protocols are followedHelps interact with corporate compliance in applicable scenariosHelps ensure public health reporting protocols are followedQualificationsRequired Work Experience: At least three years' experience and associated knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes in a Medical Laboratory-Clinical or Anatomic Pathology.Minimum of 3 years Quality Assurance experience.Preferred Work Experience:Lean Six Sigma (Continuous Improvement) experience preferredLab experience preferredPhysical and Mental Requirements: Indicate any physical or mental demands that must be met to successfully perform the principal responsibilities of the position (e.g., routinely lift 25 pounds, sitting or standing for long periods of time.)Technical /Job Specific Knowledge:Knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes in a Medical Laboratory-Clinical or Anatomic Pathology.Skills: PC application skills in Microsoft Office including Excel and Access.EducationBachelor's Degree (Medical Technology or Chemical, Biological, or Clinical Laboratory Science) (Required)Work RequirementsMinimal Travel Required - Upto 25%About the TeamQuest Diagnostics honors our service members and encourages veterans to apply. While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume. Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.