Senior Quality Assurance & Compliance Specialist jobs in United States
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Cincinnati Children's · 1 month ago

Senior Quality Assurance & Compliance Specialist

Cincinnati Children’s Hospital Medical Center is a globally recognized leader in pediatric care, research, and innovation. The Senior QA & Compliance Specialist plays a vital role in ensuring quality, safety, and regulatory excellence across specialized clinical laboratories, supporting accreditation programs and ensuring compliance. This role combines regulatory expertise, quality improvement leadership, training, and data-driven oversight to uphold the highest standards in a highly regulated healthcare environment.

Health Care

Responsibilities

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 which impact the safety of laboratory, blood bank and 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 for appropriate process, procedure and documentation. Serves as a liaison within the division or organization including affiliations with Hoxworth and other partner organizations. May maintain and control SOPs, forms and documents, maintenance records and laboratory logs. May arrange laboratory compliance support provided by the CCHMC Office of Research Compliance and Regulatory Affairs
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 to identify ongoing educational/training needs. May be responsible for documentation and compliance. Promote/market educational/training opportunities as requested. May provide related reports/data
Identify, lead, and direct process/quality improvement/assurance activities. Measure and present results of improvement efforts and ongoing performance measures of processes. In collaboration with appropriate individuals, develop strategic plans for improvement. May manage activities such as training and audits which support process improvement initiatives/activities. May participate on process improvement team(s)
Develop/design/create, evaluate, restructure, and/or manage specific database(s). Input and ensure the integrity of data and/or records. Standardize and document processes. May coordinate data collection. May conduct data analysis, create reports, and disseminate to the appropriate individuals
Participate in or collaborate in the design, objectives, and/or implementation of training/educational programs for a designated audience. May lead and/or assist with 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 and competency. Assist in Quality Assurance and Compliance activities in the Laboratory. Monitor customer and employee satisfaction data. Design, implement, evaluate and monitor patient safety programs and quality improvement projects. Provide staff guidance, education and training related to aforementioned areas. Monitor/audit and evaluate data related to aforementioned areas. Participate in research projects related to aforementioned areas. Lead activities and maintain documentation necessary for CAP and CLIA certification. Manage deviations and corrective actions

Qualification

Quality AssuranceRegulatory ComplianceClinical Laboratory ExperienceProcess ImprovementData ManagementSOP DevelopmentTraining SkillsAudit PreparationCorrective Action ManagementLeadership Experience

Required

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

Preferred

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 or maintaining SOPs, policies, or quality documentation

Company

Cincinnati Children's

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Cincinnati Children’s, a nonprofit academic medical center established in 1883, offers services from well-child care to treatment for the most rare and complex conditions.

Funding

Current Stage
Late Stage
Total Funding
$15.6M
Key Investors
Nestle Purina PetcareNational Institutes of HealthFarmer Family Foundation
2025-12-29Grant
2024-03-12Grant· $2.6M
2023-04-20Grant· $5M

Leadership Team

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Tony Johnston
Deputy Chief Information Officer, Vice President and CTO
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Company data provided by crunchbase