Florida Regional Laboratory Accreditation and Compliance Specialist

Responsibilities:

• Develops and maintains a quality management system that is consistent with recognized principles of quality assurance cGMP and cGLP practices and compliant with regulatory and accrediting  requirements in all RT-PLMI managed laboratories
• Oversees the quality management systems for main campus and other assigned location
• Partners with operational supervisory and quality point personnel at assigned location to implement the quality management systems
• Develops quality metrics for assessing compliance with critical quality management system requirements in assigned laboratories in collaboration with operational staff
• Collates and monitors data to detect trends and accrediting requirement and awareness of coming developments and changing the expectations in those requirements; e.g., ASHI, CAP, FLDOH, TJC, AABB, FDA, CLIA, HIPAA, OIG, OSHA, CMS, etc.
• Maintains continuous readiness for accreditation and regulatory inspections/surveys in collaboration with operations staff in the assigned laboratories.
• Utilizes quality assurance data to identify areas of process improvement
• Reviews and assesses the effectiveness of documented corrective actions
• Develops/provides oversight of occurrence management system and detects trends and occurrence themes.
• Recommends process improvement initiatives
• Performs internal audits to monitor compliance with regulatory and accrediting agencies the Quality Management System and  standard operating procedures
• Participates in external audits performed by outside regulatory and accrediting agencies; e.g., ASHI, CAP, AABB, COLA, CMS, FLDOH, TJC, etc.
• Collects, analyzes and organizes data/finding. Communicates findings in reports/presentations
• Monitors the proficiency testing program to ensure compliance with regulatory guidelines and appropriate review of results
• Acts as a quality assurance educator and consultant
• Other duties are assigned

Education:

• Bachelor’s degree in a Chemical, Physical, Biological or Clinical Laboratory Science

Languages:

• English

Certifications:

• None Required

Competencies (Complexity of Work):

• Requires critical thinking skills, decisive judgment and the ability to work with minimal supervision.
• Must be able to work in a stressful environment and take appropriate action

Work Experience:

• Minimum of three years of experience as  Medical Technologist
• Previous managerial or leadership experience preferred
• Additional experience in quality assurance or quality auditing preferred

Physical Requirements:

• Typical physical demands include ability to sit, stand or walk extensively
• May be required to stand and/or walk for long periods of time
• Light lifting may be required
• May be exposed to hazardous chemicals, bio-hazards, radioactive materials, communicable disease, body fluids, etc.

Personal Protective Equipment:

• Follow Standard Precautions using personal protective equipment.

Pay Range

Minimum hourly: $30.41

Maximum hourly: $46.38

The pay range displayed on this job posting reflects the anticipated range for new hires. While the pay range is displayed as an hourly rate, Cleveland Clinic recruiters will clarify whether the compensation is hourly or salary. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set, and education. This is not inclusive of the value of Cleveland Clinic's benefits package, which includes among other benefits, healthcare/dental/vision and retirement.