Senior Quality Assurance Analyst

For information technology solutions provider for the clinical, logistical and financial management of medical research in the life sciences (Numoda Technologies, Inc. d/b/a Prevail Infoworks, Inc. Philadelphia, PA): ensure that Prevail's systems remain in compliance with the regulatory guidance that governs clinical trials; responsible for leading complex validation and testing activities to ensure Prevail's computerized systems meet regulatory expectations and project requirements; provide subject matter expertise in validation strategy, test architecture, defect management and compliance oversight; support the QA team through mentorship, documentation review and risk-based testing approaches while working closely with technical and business teams to drive high-quality system releases; test and validate proprietary Prevail tools used in the production of Customer projects, according to Prevail Standard Operating Procedures (SOPs); serve as a subject matter expert in 21 CFR Part 11, ICH E6 (GCP), and validation best practices; lead and plan validation and testing efforts for complex or high-impact system releases; define and implement test strategies using risk-based and regulatory-driven approaches; review and approve validation artifacts, including test plans, traceability, and test evidence; perform advanced testing (workflow, boundary, integration, exploratory, and regression) and automation test scripts using Selenium Web driver 2.0 and Spec flow; lead defect triage, ensure proper prioritization, documentation, and resolution; support internal and external audit activities related to validation; mentor and train QA Analysts and review their work for compliance and documentation quality; recommend improvements to testing practices, validation procedures, and supporting tools; represent QA in cross-functional discussions, sprint ceremonies, and release readiness reviews; perform duties as directed by the Director of Quality Assurance Support and develop process improvement initiatives within the QA team and meet objectives as assigned. Requirements: 1. Master of Science or foreign equivalent degree in Computer Science, Computer Applications, Systems Engineering or a related field. 2. 2 years of experience in the job offered or 2 years of experience as a Quality Assurance Analyst. The required experience must include validation strategies, test management and defect tracking tools such as Jira to write and execute test scripts, based on approved functional specification. 3. Proficiency in SDLC, Agile methodology, and GxP validation principles. 4. Familiarity with FDA 21 CFR Part 11, ICH E6 (GCP), HIPAA, and ISO guidelines. 5. Knowledge of SQL and C#. 6. National telecommuting. Please submit your resume to the company at the following: Madeline Ward, HR Coordinator, Numoda Technologies, Inc. d/b/a Prevail Infoworks, Inc., [email protected]