Overview
Skills
Job Details
We are seeking an experienced Quality Assurance (QA) Specialist with a strong background in clinical trials within the pharmaceutical industry. The ideal candidate will have hands-on experience ensuring data integrity and system compliance across clinical systems and cloud technologies.
Key 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.
Required Skills & Experience:
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.
SQL and Athena for data validation.
Python (ability to read and understand code).
Microsoft Excel (pivot tables, linked spreadsheets).
Familiarity with Jira for issue tracking and Agile workflows.
Experience in:
Creating and executing test plans and scenarios.
Performing regression testing and ensuring system stability.
Managing defects and collaborating with cross-functional teams.
Strong analytical and problem-solving skills with attention to detail.
Preferred Qualifications:
Understanding of clinical data standards (CDISC, SDTM).
Knowledge of GxP compliance and regulatory requirements.
Excellent communication and documentation skills.