Senior Laboratory Quality Assurance and Control Specialist
2 weeks ago
The Senior Laboratory Quality Assurance and Control Associate will be responsible for the administration and management of all aspects of the quality program for multiple labs. This includes overseeing, planning, coordinating, and implementing quality control and quality assurance initiatives in accordance with the quality program.
Key Responsibilities- Develops, implements, and maintains laboratory quality control and quality assurance program.
- Determines audit goals, plans audit activities, and performs assessment of compliance with meeting those goals.
- Assists in handling procedural and technical laboratory issues immediately by analyzing the root cause of the problems and incorporating procedural changes to prevent the problems from reoccurring.
- Communicates discrepancies or deviations to the appropriate personnel to be resolved.
- Reviews and monitors quality control shifts and trends and takes appropriate actions when necessary.
- Assists with monitoring and maintaining regulatory compliance with accrediting agencies.
- Prepares and ensures readiness of regulatory agencies surveys and internal surveys.
- Assists in all phases of regulatory compliance surveys.
- Develops, implements, and maintains laboratory quality control processes and procedures and conducts audits to ensure compliance of regulatory agencies.
- Maintains and monitors biohazardous and regulated medical waste generation, disposal, and reporting.
- Maintains and monitors cancer reporting to regulatory agencies.
- Assists in monitoring all phases of proficiency testing and competency assessments.
- Assists in the installation and validation of laboratory equipment.
- Assists in the validation and optimization of laboratory tests.
- Ensures equipment and instruments are maintained and calibrated annually and schedules preventative maintenance and service.
- Manages equipment document control, vendor notifications, and recalls.
- Troubleshoots laboratory equipment and instruments as needed and documents appropriately.
- Attends training for the equipment and instruments as needed.
- Maintains hazardous chemical inventory and collaborates with the Office of Environmental Safety.
- Maintains safety data sheets.
- Ensures cleanliness and organization of all departments.
- Collaborates with clinics as needed to ensure overall lab standards are met.
- Understands practical management approaches such as management of workflow, quality review, coaching, and performance management.
- Supports lab inspections for partnering hospital affiliates.
- Manages document control.
- Other duties not previously designated.
- Bachelor's degree.
- Four years of relevant experience.
- Master's Degree.
- Two years of Histology laboratory experience with experience in laboratory inspections (CAP, JCAHO, CLIA), as well as experience with quality control initiatives.
- MLS (Medical Lab Scientist), HT (Histotechnologist) or equivalent through ASCP Board of Certification.
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