Quality Assurance Analyst

ECS is seeking an experienced Quality Assurance Analyst to work remotely providing cybersecurity support for the work performed under this contract for NIH NIAID Enabling and Advancing Technologies (NEAT). All other tasks are intended to facilitate the implementation and operation of Enterprise Clinical Information Systems. This engagement provides a spectrum of management, technologies development, applications/software engineering, bioinformatics support, and professional development.

Please Note: This position is contingent upon [contract win].

The NIAID NEAT Quality Assurance Analyst will be responsible for providing technical and administrative direction for personnel performing software development tasks, including the review of work products for correctness, adherence to the design concept and to user standards, review of program documentation to assure government standards/requirements are adhered to, and for progress in accordance with schedules.

Key Responsibilities:

• Provide technical and administrative direction for personnel performing software development tasks, including the review of work products for correctness, adherence to the design concept and to user standards, review of program documentation to assure government standards/requirements are adhered to, and for progress in accordance with schedules.
• Coordinate with the Project Manager and/or Quality Assurance Manager to ensure that problems are solved to the user’s satisfaction.
• Make recommendations, if needed, for approval of major systems installations.
• Prepare milestone status reports and deliveries/presentations on the system concept to colleagues, subordinates, and end user representatives.

• Minimum 3 years of quality assurance experience supporting Health IT software development initiatives.
• Bachelor’s degree in computer science, Information Security or related field.
• Active Public Trust or higher security clearance.
• Proficiency in establishing and maintaining quality control processes.
• Knowledge of determining resource requirements for quality control.
• Demonstrated experience in maintaining quality levels throughout the software lifecycle.
• Ability to conduct effective formal and informal reviews.
• Familiarity with domestic and international regulatory and compliance requirements for clinical research.
• Familiarity with using the GAMP approach for 21 CFR Part 11 compliance.
• Understanding of regulatory inspection processes.
• Experience developing Computer Systems Validation/Computer Systems Assurance documentation.
• Competency in risk identification and management, root cause analysis, and corrective and preventive action (CAPA) management.
• Competency in verbal communication, technical written communication, and analytical skills.
• Reside within the Washington DC Metro area.
• Travel within the Washington DC Metro Area, and CONUS as needed.