Accreditation and Compliance Specialist - PRN

Cleveland Clinic • Cleveland, OH • 2h ago

Ensures compliance with regulatory and accrediting agencies (e.g. ASHI, CAP, ODH, TJC, OSHA, FACT, FDA, EPA, AABB, NRC, etc.). Maintains the Pathology and Laboratory Medicine (PLM) Quality Management System utilizing recognized principles of quality assurance, current good manufacturing practices (cGMP) and current good laboratory practices (cGLP). Performs internal audits of laboratory practices and monitors programs and quality metrics to ensure that activities are consistent with regulatory requirements, the Quality Management System and standard operating procedures. Reviews and evaluates compliance gaps and recommends process improvements. Conducts audits. Reviews corrective actions for errors or failures and reports deviations to PLM Leadership. Analyzes data and prepares reports. Acts as a quality and compliance educator and consultant to operational staff.

Responsibilities:

Assists with maintaining compliance with the quality management system that is consistent with recognized principles of quality assurance cGMP and cGLP practices

Oversees operational practices and ensure compliance with regulatory and accrediting requirements in all PLM managed laboratories throughout the Cleveland Clinic Health System, including Florida.

Oversees the quality management system for main campus and for other assigned locations.

Partners with operational supervisory and quality point personnel at assigned locations to implement the quality management system.

Collates and monitors data to detect trends and ensure compliance with regulatory requirements and quality essentials.

Maintains current knowledge of regulatory and accrediting requirements, and awareness of coming developments and changing expectations in those requirements; e.g., ASHI, CAP, TJC, AABB, FDA, CLIA, HIPAA, OIG, OSHA, CMS, etc.

Maintains continuous readiness for accreditation and regulatory inspections/surveys in collaboration with operations staff in assigned laboratories.

Utilizes quality assurance data to identify areas for process improvement.

Reviews and assesses the effectiveness of documented corrective actions.

Develops/ provides oversight of occurrence management system and detects trends and occurrence themes.

Performs internal audits to monitor compliance with regulatory and accrediting agencies, the Quality Management System and standard operating procedures

Collects, analyzes and organizes data/findings. Communicates findings in reports/ presentations.

Monitors the proficiency testing program to ensure compliance with regulatory guidelines and appropriate review of results.

Leads main campus CAP inspection preparation for both the self-inspection and the outside inspection.

Acts as a quality assurance educator and consultant.

Other duties as assigned.

Education:

Bachelor's degree in a chemical, biological or Clinical Laboratory Science.

Languages: English

Certifications: None required

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:

Have three years of clinical laboratory training or experience, or both, in non -waived testing.

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 diseases, body fluids, etc.

Personal Protective

Follows Standard Precautions using personal protective equipment.

Pay Range

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