Quality Assurance (QA) Specialist Job at Tandym Group, Cambridge, MA

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  • Tandym Group
  • Cambridge, MA

Job Description

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

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