Specialist, Quality and Regulatory Affairs

Job Description - Specialist, Quality and Regulatory Affairs (260007MI)

Specialist, Quality and Regulatory Affairs - ( 260007MI )

This position is responsible for providing support to the quality and regulatory activities within Pathology. Areas of focuses for the Quality Department are driving overall process improvement, workflow mapping and development, conduct safety reviews, coordinate response efforts to nonconformances, development of educational content and tools to improve quality outcomes, and ensure compliance with regulatory and accreditation entities. This role manages ad hoc projects that fall into these categories for the system, as well as long-term initiatives, with the overarching goal of creating standardization to ensure the same, high quality experience for all patients interacting with UH Pathology.

• Lead internal and external regulatory surveys and inspections, and standardize response process across the system. Responsible for achieving and maintaining compliance with regulatory and accrediting agencies (e.g. CAP, CLIA, ODH, DNV, FDA, ASHI, etc.) for all laboratory sections and locations across all patient settings. Orders, monitors and coordinates proficiency testing survey program and ensures compliance with Clinical Laboratory Improvement Amendments (CLIA).
• Develop Media Lab content in Compass and Document Control modules to align with strategic goals and regulatory standards, with the goal of achieving standardization policy and procedure organization across the system.
• Serve as representative on a variety of Quality related committees to create system alignment in Quality and Regulatory affairs for the system, as well as disseminate recall and safety notices throughout the system.
• Manage and develop system-wide database containing quality metrics for various laboratory sections. Pull data for quality indicator review for the various sections within pathology for review at Quality Management meetings, and facilitate Quality Management meetings. Coordinate development and implementation of action plans when metrics fall below acceptable threshold.
• Participate in Learning From Defects reviews and project manage action items coming out of the meeting to close the loop on patient safety issues, as well as disseminate solutions and best practices to the system.
• Manage partnerships with educational institutions, coordinate clinical rotations for students, and create pathways for existing employees to further their educated and become eligible for additional credentials/certification.
• Provides analytical support related to operations and finance. Access and analysis of information to support key strategic initiatives. Monitors various reports and data. Work on assigned projects aimed at improving processes, enhancing revenue, and reducing costs.
• Lead training sessions for external stakeholders regarding regulatory compliance. Lead internal training sessions regarding use of policy/competency assessment software (Media Lab) as well as training of new hires.

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

• Bachelor's Degree In chemical, physical or biological science or medical laboratory (Preferred) and
• Associate's Degree In chemical, physical or biological science or medical laboratory (Required) and
• High School Equivalent / GED with documented training prior to 9/1/1997 and performance of high complexity training on or before 4/24/1995 (Required)

• 5+ years Experience working in the medical laboratory (Required)

• Proficiency with Microsoft Office, including advanced knowledge of Excel (Required proficiency)
• Proficiency with Laboratory Information Management Systems (LIMS) (Required proficiency)
• Wo…