-Continued all previous responsibilities performed as a Software Quality Analyst.-Helped build a team of Software Testers and two additional Software Analysts by participating in the interview and hiring process including both phone and in-person interviews.-Trained each software tester and analyst and worked through an on-boarding process involving Company and Departmental SOPs, Software programs used by the teams to support test execution and the workflow of testing and capturing evidence for validation verification.-Helped review and approve test scripts written for requirements testing by the Software Analysts.

-Hired as the Software Analyst to coordinate with the company's Senior Director of Quality and Compliance in order to help plan and manage validation efforts across multiple products that make up the the complete Clinical Ink Software Platform. -Maintained and created multiple suites of test scripts and test plans for every device and software product requiring validation as part of the SDLC. Focus of testing was not only on software UI and device workflows, but also on back-end data export configurations and web services testing. -Maintained comprehensive tracking for all defects found during testing. -Ensured all documentation included in each release was complete and satisfied any requirements or bug fixes included in the scope of the validation plan. Mitigated any risk as necessary.

• Evaluates new and updated systems to determine the necessary validation steps to assure compliance of all Cardiac Safety systems with industry standards and regulatory requirements.• Writes concise and complete documentation to support the validation of clinical data systems. This includes the collection of vendor supplied documentation, as appropriate.• Coordinates with operational management in the identification, oversight, and training of end users in the execution of test scripts.• Evaluates results from assigned test programs to ensure accurate and complete documentation and results.• Maintains comprehensive tracking of all test deviations and associated corrective action.• Assists in the audit of external vendors providing technologies or services related to clinical trials• Evaluates clinical systems for compliance with ERT standard operating procedures, internal development standards, and regulatory authorities.• Performs ongoing quality reviews of clinical data systems.• Assists in the development of standard operating procedures related to the development, evaluation, implementation, and testing of clinical data systems.• Provides consulting services to contracted external sources as required.

Supporting and helping lead a core lab operations team deliver ECG and 12-lead ambulatory holter analysis in the support of global clinical trials for cardiac safety drug research.