The Federal Health Operation has an opening for a Test Analyst located at Ft. Detrick, MD. Position is with the Enterprise Information Technology (IT) Project Management Office (PMO), supporting medical research. Candidate will work for the Leidos Project Manager but is expected to work independently and accomplish assignments without much direction.
Perform test planning, develop test plans and test scripts, and execute testing on eIT PMO products, ensuring that they function as expected. Work with Product Leads to implement software patches, upgrades, and new products. Participate in the Change Management (CM) process to verify that all changes to IT systems are tested appropriately. Ensures quality of software products.
- Design, write and supervise the execution of "Software Implementation and Test Plans" to define the tests that will be performed following a system change.
- Review and create test scripts to test requirements and functionality of application software.
- Work with Test/Validation Lead to ensure that the Change Management (CM) and testing processes maintain the FDA 21 CFR Part 11 validated state of regulatory applications, as well as the foundation software and hardware. Work in conjunction with USAMRMC Office of Regulatory Activities (ORA) to maintain validated state throughout the change management process.
- Prepare test reports as well as writes/edits deviations and product problem reports.
- Work closely with Product Leads and System/Database/Product Administrators in determining the level of testing and what areas are to be tested depending on the change that is being implemented.
- Ensure complete documentation of test and validation process in a quality manner.
- Perform role of Test Librarian including managing electronic documents, hardcopy validation and test documentation, as required by regulation.
- Write/edit SOPs, work instructions, training presentations, and other documents to refine and streamline testing processes.
- Provide training to eIT PMO staff on various testing, documentation, and validation related work instructions and Standard Operating Procedures (SOPs).
- Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee may be required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
- Ability to perform tasks with a minimum of supervision.
Additional Specific Duties :
Create test plans and test scripts which will test functionality against requirements and identify defects. Prepare test reports that document test results and capture defect data. Evaluate test results and be able to communicate them with both technical and non-technical individuals (i.e., management, Product Leads, etc.) to provide status and support decision making. Analyze requirements and system processes to ensure complete test coverage and requirement testability. Participate in the remediation of defects by recreating identified defects to assist in the troubleshooting process. Participates in defect tracking with the Engineers and Product Leads to ensure defects are resolved in a timely manner. Evaluates testing processes and methods to ensure consistency based on standards. Responsible for ensuring procedures and software have been implemented in a quality manner to support FDA 21 CFR Part 11 regulations (where required) and GAMP compliance. Familiarity with Army REQs and RMF Work in close collaboration with other functional teams during the life cycle of the system. Review change requests and change proposals with regards to effect on validation state of application and determine level of testing required to maintain validated state. Ensure validation and test documentation are executed in accordance with eIT PMO processes and procedures and documented in a quality manner. Work with Product Leads to determine an efficient testing and release strategy when bundling changes Support the overall project with quality assurance and control support as needed or directed.
- Bachelor's Degree or relevant formal accreditation related to IT testing and validation is required.
- 3 to 5 years' experience
- Must have excellent English, writing, and interpersonal communication skills.
- Strong problem solving skills and ability to be a team player.
- Must be able to successfully complete a background investigation and obtain a clearance for positions of public trust.
- U.S. citizen
- Must be able to work independently following brief periods of specific technical training.
- Proficient in Microsoft Office including Word, Excel, PowerPoint, and Project.
- Experience in Department of Defense Information Technology preferred.
- Experience with FDA validation and 21 CFR Part 11 is preferred.
- Be able to perform testing of each software application and understand when a defect is present.
- Familiar with Configuration Management processes