Evaluate, design and implement the lab quality assurance program to ensure that the laboratory is compliant to the regulatory requirements for the continued accreditation and certification of CAP and CLIA. The Clinical Laboratory Quality Assurance Manager will be responsible for monitoring the Lab Quality Management program, implement new plan for improvement and to meet with updated requirements. This individual will maintain all documents including SOP, policies and forms pertaining to the lab operations.
- Manage the review and development of technical and SOPs, to ensure compliance with appropriate regulations.
- Utilize root cause analysis to evaluate all systems for correction, recommend action and professionally communicate to management the analysis to continually improve quality.
- Design, develop and implement new QC procedures.
- Monitor implementation as designed.
- Use of metrics, benchmarks and indicators for quality.
- Responsible for Proficiency Testing scheduling and events.
- Perform internal audits (CAP interim, competency assessments, quality indicators, periodic audit of QM Plan)
- Ensure all laboratory activities are performed in accordance to CAP requirements.
- Maintain all documentation required for licensure purposes.
- Lead QC staff meetings and discuss findings and recommendations for resolving non-compliance.
- Demonstrate continuous self-motivated quality development.
- Proactively take steps to improve quality systems.
Job Qualifications & Skills
- Education: Bachelor’s Degree required.
- Experience: 7 years’ experience in quality assurance within CAP/CLIA laboratory environment required.
- California Clinical Laboratory Scientist License and certified MT/MLS ASCP preferred.
- Knowledge of word-processing, spreadsheet, and database applications.
- Knowledge of document control in lab environment
- Knowledge of CAP/CLIA regulations and guidelines
- Strong interpersonal skills, verbal and written communication.
- Effective organization and problem-solving skills.
- Ability to initiate assigned tasks and to work independently.
- Capability to manage multiple projects and train.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.