QA Analyst

1. Quality Assurance Management:
   
   
   
   1. Assist in the development, implementation, and maintenance of the quality assurance programs and processes.
   
   
   2. Monitor and assess laboratory performance to ensure compliance with internal and external quality standards.
   
   
   3. Conduct routine audits of laboratory procedures, tests, and equipment to verify adherence to established protocols.
   
   
   
   

1. Compliance & Regulatory Monitoring:
   
   
   
   1. Ensure all laboratory operations comply with regulatory bodies such as CLIA, CAP, and COLA standards.
   
   
   2. Assist in preparation for inspections or accreditations and ensure that corrective actions are implemented as required.
   
   
   3. Maintain accurate records of quality audits, inspections, and any corrective or preventive actions (CAPA).
   
   
   
   

1. Data & Documentation Review:
   
   
   
   1. Review and analyze laboratory data to detect trends, errors, or anomalies that could affect testing results.
   
   
   2. Ensure proper documentation practices are followed in the handling, storage, and reporting of laboratory data.
   
   
   3. Support the creation, revision, and implementation of standard operating procedures (SOPs).
      
      
   
   
   
   


2. Training and Support:
   
   
   
   1. Provide training and guidance to laboratory staff on quality assurance practices, regulatory requirements, and standard operating procedures.
   
   
   2. Assist in the development of training programs to promote a culture of continuous quality improvement in the laboratory.
   
   
   
   

1. Continuous Improvement:
   
   
   
   1. Lead or participate in continuous improvement projects aimed at enhancing laboratory performance, accuracy, and efficiency.
   
   
   2. Collaborate with laboratory managers and staff to implement best practices and drive improvements in testing accuracy and turnaround times.
   
   
   
   

1. Incident Investigation:
   
   
   
   1. Investigate and resolve any discrepancies, errors, or non-conformities in laboratory testing or processes.
   
   
   2. Assist in the development and implementation of corrective and preventive actions (CAPA) to address identified issues.
   
   
   
   

1. Reporting and Communication:
   
   
   
   1. Prepare detailed quality assurance reports for management, summarizing audit findings, trends, and recommendations.
   
   
   2. Communicate effectively with laboratory personnel, management, and external regulatory bodies when necessary.
   
   
   
   

Job Requirements

• Previous experience in clinical laboratory quality assurance, laboratory operations, or regulatory compliance preferred.


• Strong knowledge of laboratory testing, regulatory guidelines, and best practices.


• Excellent attention to detail and ability to interpret complex data and documentation.


• Strong communication and interpersonal skills, with the ability to train and support staff.


• Proficiency in laboratory information systems (LIS) and quality management software.


• 10% travel may be required.

Physical Requirements and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Prolonged periods of sitting at a desk and working on a computer


• Occasionally required to lift and/or move up to 15 pounds

While performing the duties of this job, the employee is frequently required to stand: to handle or feel: to talk and to hear. The employee occasionally is required to walk, sit: reach with hands and arms and stoop, kneel, crouch or crawl. The employee may lift and or move up to 15 pounds on occasion. Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus.

Education and Experience Requirements

• Associate degree in Medical Laboratory Science, Clinical Laboratory Science, Biology, or a related field (or equivalent experience).


• Certification from a recognized agency (e.g., ASCP, CLS, or equivalent) is preferred.