Sr Associate IS Analyst

Career Category

Job Description

Role Overview

The Tester is responsible for executing testing and validation activities for clinical data, analytics, and reporting systems, with a strong focus on data validation, pipeline testing, and Agile delivery to ensure high-quality and reliable releases.

Key Responsibilities

• Execute end-to-end testing (SIT, UAT, IQ, OQ, Dry Runs) including test design, execution, and defect management using VVM/Veeva Vault and ALM
• Perform data validation across ETL/ELT pipelines, including SQL-based reconciliation, source-to-target validation, and verification of datasets, reports, and dashboards
• Validate system functionality, data transformations, and integrations across GxP and Non-GxP systems based on business and regulatory requirements
• Analyze and resolve data issues through defect triaging, production data validation, and ensuring data accuracy and integrity
• Ensure completeness and correctness of testing artifacts, including test scripts, execution evidence, and defect documentation for audit/inspection readiness
• Maintain end-to-end traceability (RTM) between requirements, test cases, execution results, and defects
• Support validation lifecycle activities including impact assessment, risk-based testing approaches, and validation documentation updates
• Support execution and closure of validation activities aligned with Change Requests (ServiceNow) ensuring proper documentation and approvals
• Participate in release readiness activities including test summaries, defect reviews, and go/no-go decisions
• Collaborate with Agile teams (BA, Dev, QA, Product) to deliver sprint testing outcomes and ensure timely, high-quality releases
• Contribute to continuous improvement of testing and validation practices, including standardization and automation-aligned approaches

Required Qualifications

• 5–8 years of experience in testing, QA, or data validation roles
• Strong experience in test case design, execution, defect lifecycle management, and test documentation
• Experience with testing tools such as HP ALM, JIRA, and Confluence
• Familiarity with functional, integration, and data validation testing approaches
• Experience working in Agile/Scrum delivery models
• Strong analytical, debugging, and problem-solving skills
• Ability to work with cross-functional teams and deliver within sprint timelines

Must Have

• Strong SQL expertise for data validation, reconciliation, joins, aggregations, and exception analysis
• Hands-on experience testing ETL/ELT pipelines (Databricks or similar) and validating data across relational databases
• Experience working with AWS data services (S3 ingestion/storage) and SQL tools (DBeaver or similar)
• Strong understanding of source-to-target validation, data quality checks, and data defect analysis
• Experience preparing test evidence and supporting validation execution in controlled environments

Good to Have

• Knowledge of Computer System Validation (CSV)
• Understanding of Risk-Based Validation (RBV)
• Familiarity with GxP and 21 CFR Part 11
• Experience with Veeva Vault / VVM

Preferred Skills

• Experience in clinical data, analytics, or reporting systems
• Familiarity with data warehouse / data lake validation concepts
• Exposure to test automation or automation-aligned practices
• Strong documentation and communication skills

Leading biotechnology company focused on oncology, cardiovascular, bone health, and inflammation therapies. Based in Thousand Oaks, CA.

amgen.com