At Cincinnati Childrens Hospital Medical Center (CCHMC)a globally recognized leader in pediatric care, research, and innovation-the Senior QA & Compliance Specialist plays a vital role in safeguarding quality, safety, and regulatory excellence across our specialized clinical laboratories. This position supports complex clinical lab accreditation programs in New York and California, collaborates with the Clinical Lab QA Domain, and ensures compliance across the CBDI Clinical Labs. Serving as a key partner during audits conducted by pharmaceutical companies and external collaborators, this role combines regulatoryexpertise, quality improvement leadership, training, and data-driven oversight to uphold the highest standards of patient safety, research integrity, and operational excellence in a highly regulated healthcare environment.

JOB RESPONSIBILITIES

• Quality Assurance Leadership -Under general direction, coordinates laboratory quality assessment and improvement activities, safety and regulatory compliance, and staff education and competency relating to quality. Audit/monitor pre and post testing variables whichimpactthe safety of laboratory, bloodbankand transfusion practice. Develop new systems to improve system performance within allotted resources. Coordinate an effective communication plan for system improvement notices or reminders. Coordinate audits of laboratory practices forappropriate process,procedureand documentation. Serves as a liaison within the division or organization including affiliations with Hoxworth and other partner organizations. Maymaintainand control SOPs, forms and documents, maintenancerecordsand laboratory logs. May arrange laboratory compliance support provided by the CCHMC Office of Research Compliance and Regulatory Affairs.

• Training - Delivery III -Collaborate in the formal or informal training, education, and/or development of staff, new employees, patients, visitors, students, fellows, residents, and/or the community. May collaborate toidentifyongoing educational/training needs. Maybe responsible fordocumentation and compliance. Promote/marketeducational/trainingopportunities asrequested. May provide related reports/data.

• Process Improvement II -Identify, lead, and direct process/quality improvement/assurance activities. Measure and present results of improvement efforts and ongoing performance measures of processes. In collaboration withappropriate individuals, develop strategic plans for improvement. May manageactivities such as training and audits which support process improvement initiatives/activities. Mayparticipateonprocess improvement team(s).

• Data Management III -Develop/design/create, evaluate, restructure, and/or manage specific database(s). Input and ensure the integrity of data and/or records.Standardizeand document processes. May coordinate data collection. May conduct data analysis, create reports, anddisseminate totheappropriate individuals.

• Training - Content Development II -Participatein or collaborate in the design,objectives, and/or implementation of training/educational programs for a designated audience. May lead and/orassistwith the preparation of related reports and/or presentations. May provide input on training needs and/or evaluate training outcomes. May investigate or recommend new training tools/approaches.

Under general direction, coordinates quality assessment and improvement activities, safety and regulatory compliance, and staff education andcompetency.Assistin Quality Assurance and Compliance activities in the Laboratory. Monitor customer and employee satisfaction data. Design, implement,evaluateandmonitorpatient safety programs and quality improvement projects.Providestaff guidance,educationand training related to aforementioned areas. Monitor/audit and evaluate data related to aforementioned areas. Participate in research projects related to aforementioned areas. Lead activities andmaintaindocumentation necessary for CAP and CLIA certification. Manage deviations and corrective actions.

Required Qualifications

• Bachelor of Science in a related discipline OR an equivalent combination of education and experience

• Minimum of 2 years of work experience in a related job discipline

PreferredQualifications

• Prior supervisory or leadership experience

• Certification from a nationally recognized certifying agency

• Experience supporting clinical laboratory quality assurance and compliance activities

• Familiarity with CAP and CLIA accreditation requirements and audit preparation

• Experience with process improvement initiatives and corrective action management

• Experience developing ormaintainingSOPs, policies, or quality documentation