Senior Quality Assurance & Compliance Specialist

Cincinnati Children's Hospital Medical Center•Cincinnati, OH

11d•Onsite

About The Position

At Cincinnati Children's 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 regulatory expertise , 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.

Requirements

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

Nice To Haves

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

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 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.
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 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.
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 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).
Data Management III - 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 .
Training - Content Development II - 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.