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University of Rochester Quality Assurance and Compliance Specialist, Laboratory Medicine - 232033 in Rochester, New York

Quality Assurance and Compliance Specialist, Laboratory Medicine Job ID 232033

Location Strong Memorial Hospital Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 052 Lab Admin-Clin Labs SMH



Oversees the quality & compliance program initiatives for the Division of Pathology and Laboratory Medicine. Following division quality/compliance standards and protocols, ensures consistent quality/compliance programs and standards within the department. Communicates and enforces applicable federal and state regulatory requirements and industry standards to laboratory Supervisors and staff. Monitors department compliance with quality/compliance procedures and programs. Collaborates with laboratory staff to promote regulatory compliance. Coordinates audits, inspections, and monitoring visits from customers and regulatory agencies.


  • Under general direction and with latitude for independent judgment:

  • Monitors Quality Assurance & Compliance Program for UR Medicine Labs and affiliates. Conducts internal audits, prepares audit reports, tracks internal audit responses and monitors/documents action taken to correct all deficiencies at all sites. Assists in the development of section specific quality assurance/compliance plans and procedures. Collaborates with internal departments to develop quality monitors in accordance with industry standards. Monitors Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Practice Evaluation (OPPE) programs. Coordinates data submission and review of department standard metrics. Evaluates and makes recommendations regarding audit outcomes, data analysis and departmental key indicators, including Clinical Trials project specific indicators. Support activities related to billing compliance, as needed

  • Monitors occurrence management initiatives and assists staff in developing quality improvement plans. Assists in the development of Corrective Action and Preventative Action (CAPA) plans. Tracks the progress of CAPA/quality improvement initiatives. Provides department management with regular updates on quality systems initiatives.

  • Participates in the development and execution of the UR Medicine Lab Quality & Compliance Plans. Assists in the development department policies & procedures. Assists with the preparation of a yearly Quality & Compliance Report.

  • Monitors document management process, ensuring that related documents and records are in accordance with UR Medicine Labs policy, state and federal guidelines. Maintains documents and records according to protocol requirements and state and federal health care standards.

  • Assists with external audit schedules. Tracks progress of corrective action plans related to audit finding.

  • Maintains current knowledge of developing trends in quality systems methods, state and federal regulations and incorporates such into department programs. Researches state/federal regulations and current industry standards to provide guidance for compliance and best practices. Conducts risk assessments of current processes against regulations and industry standards.


    Bachelor’s degree in a related field, with 1-2 years of clinical, quality, or management experience; or an equivalent combination of education and experience. Laboratory experience and/or familiarity with the regulatory environment is preferred.

    NOTE: This document describes typical duties and responsibilities and is not intended to limit management from assigning other work as required.

    How To Apply

All applicants must apply online.

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