Tandym Group
Quality Assurance (QA) Specialist (Cambridge)
Tandym Group, Cambridge, Massachusetts, United States, 02140
A recognized pharmaceutical company is actively seeking a new Quality Assurance (QA) Specialist to ensure data integrity and system compliance across clinical systems and cloud technologies.
Responsibilities:
Develop, document, and execute test plans, scenarios, and test cases for clinical trial applications and data workflows
Perform functional, regression, and integration testing to validate new features and ensure existing functionality remains intact
Utilize QTest for test management and documentation
Conduct defect management, including logging, tracking, and verifying fixes
Collaborate with development teams in an Agile environment to ensure timely and accurate testing
Identify and resolve data quality issues at the business level, ensuring compliance with regulatory standards
Work closely with stakeholders to validate requirements and deliver high-quality solutions
Qualifications:
5+ years of QA experience in the Clinical Trials / Pharma domain
Strong knowledge of AWS, Databricks, and clinical systems (CTMS, EDC, eTMF)
Proficiency in QTest for test case management
Experience with SQL and Athena for data validation
Experience with Python (ability to read and understand code)
Microsoft Excel (pivot tables, linked spreadsheets)
Familiarity with Jira for issue tracking and Agile workflows
Strong analytical and problem-solving skills with attention to detail
Desired Skills:
Solid understanding of Clinical Data standards (CDISC, SDTM)
Knowledge of GxP Compliance and Regulatory requirements