Quality Assurance Specialist

Position Summary: 

The Quality Assurance Specialist aids the Quality Assurance Manager in areas to include regulatory and compliance related tasks. The Quality Assurance Specialist is responsible for the coordination and implementation of the Laboratory's quality programs. This position is also responsible for assessing patient test management, Pre-analytical, Analytic and Post Analytic processes; review and compilation of incident reports; and implementing corrective regulatory requirements. This position designs and standardizes procedures for documentation, review of test results, performance and monitoring of quality control, corrective action, proficiency testing, and equipment management as well as develops and monitors competency assessment, training, and corrective actions. 

Essential Job Duties: 

Major Responsibilities 

• Implementation and maintenance of patient test quality management, Pre-analytical, Analytic and Post analytic processes. 

• Conducts periodic audits of the laboratory to ensure compliance of all areas with the policies of the laboratory and reports non-compliance. 

• Coordinates inspections by regulatory agencies, such as CLIA. 

• Responsible for maintaining licenses and registrations; facilitating applications and renewals or any other inspection-related activities. 

• Coordinates the proficiency testing activities by facilitating the subscription of required proficiency testing materials, ensuring the testing are performed and results are submitted in a timely manner. Ensures that appropriate follow up on corrective action is implemented when test result/s is found unsatisfactory. 

• Drafts policies, procedures and forms for laboratory Quality Management System. 

• Recommend, create, implement, and update SOPs, as necessary, to improve processes, and support compliance. 

• Develops and maintains document workflows for editing, review and approval. 

• Conducts training on policies and procedures. 

• Monitors QA indicators and establishes criteria for monitoring service. Generates reports to track performance and quality improvement. Assists in developing QA plans. Collects and collates data and implements changes to resolve problems. Provides support for the creation of QA reports for regulatory agencies. Prepares annual quality assurance report and submits for review. 

• Maintains up-to-date knowledge and understanding of local, state and federal requirements and regulations set forth by CLIA and such agencies. 

• Enforces the laboratory safety program through training, monitoring and remediation. 

• Provides key regulatory expertise to leadership and all cross-functional project teams with regard to regulations pertaining to development of the company's products and services. 

• Leads quality audits of laboratory operations, documents audit findings, and reports results to senior leadership. 

Required Education/Degree: Bachelor's degree in a work-related discipline/field from an accredited college or university. Master’s degree in a work-related discipline/field preferred. 

Required Certification/License: 

None 

Required Work Experience: 

Five (5) years of progressively responsible and directly related clinical laboratory work experience.  

Training in Excel, Word, Access and other computer programming is preferred.  

Training in SelectIS Laboratory Information System and CareLogic Medical Information System will be provided.  

Other Duties: 

Knowledge of and understanding of the processes, methods, and operations in functional area(s) of responsibility. Knowledge of local, state, and federal regulatory requirements related to areas of functional responsibility. Ability to analyze data, draw conclusions and interpret results. Ability to communicate effectively, both orally and in writing. Ability to plan, organize, develop tactical plans, and set priorities. Ability to solve problems and identify solutions. Ability to work effectively with individuals at all levels of the organization.  Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.