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Senior Quality Assurance Specialist

Company: Rochester Regional Health Systems
Location: Rochester
Posted on: November 19, 2021

Job Description:

SUMMARYAs a part of the Quality Assurance team, the Quality Assurance Specialist promotes and supports a culture of audit readiness within ACM Global Laboratories. Responsible for hosting customer audits & regulatory inspections, conducting internal audits, managing Quality Issue (QI) tracking, managing Corrective Actions & Preventive Actions (CAPA) and developing/ maintaining Standard Operating Procedures (SOPs). STATUS: Full-timeLOCATION: 150 Elmgrove RdDEPARTMENT: Quality AssuranceSCHEDULE: Monday - FridayATTRIBUTESBachelor's degree or at least 10 years of Quality Assurance experience in the healthcare industry required.3 years of Quality Assurance experience is required; experience in Laboratory, Pharmaceutical or Clinical Research Organization (CRO) preferred.Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA, strong preferred.RESPONSIBILITIESQuality Assurance Independently perform a wide range of activities to support the Quality Assurance department by participating in the processes required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organization. Serve as Quality Assurance contact for assigned customers & functional areas (as required). Prepare for, carrying out, report and follow up of Quality Assurance required audits - including internal, 3rd party and vendor audits. Participate in review of root cause analysis, corrective action & preventive action plans for internal, 3rd party & vendor audits. Provide oversight & participate in review root cause analysis, corrective action & preventive action plans for Quality Issues & customer complaints. Process Improvement Support the processes in place to ensure customer complaints are appropriately raised and handled. Support the processes in place to ensure internally identified Quality Issues are appropriately raised and handled. Lead the development of QA SOPs & processes, the Quality Manual and other organizational SOPs & processes where required. Participate in Lean/Six Sigma, process improvements. Training Serve as a resource promoting the development and understanding of the key elements related to Quality Management Systems & regulatory compliance requirements including training opportunities to staff at an organizational level.

Keywords: Rochester Regional Health Systems, Rochester , Senior Quality Assurance Specialist, Other , Rochester, New York

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