Clinical Quality Assurance Specialist II at Thermo Fisher Scientific in Fishers, Indiana

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)



Job Description



The CLIA Laboratory Quality Specialist II is responsible for the maintenance of the Laboratory's quality programs. This position is also responsible for assisting with assessing patient test management, Pre-analytical, Analytic and Post Analytic processes; review and compilation of complaints and incident reports; and implementing corrective regulatory requirements. This position helps standardize procedures for documentation, review of test results, performance and monitoring of quality control, corrective action, proficiency testing, and equipment management as well as monitor competency assessment, training, and corrective actions.



Key Responsibilities:

• Maintaining patient test quality management processes.


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


• Assists during inspections by regulatory agencies, such as CLIA/CAP.


• Assist with 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.


• 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 requirements and regulations set forth by CLIA and such agencies.


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

• Bachelor's degree in a work-related discipline/field from an accredited college or university.


• One to two years of progressively responsible and directly related clinical laboratory work experience.


• 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.