Sr. Validation Services Analyst
Core
Lead validation activities for clinical technology solutions to ensure accuracy and reliability for sponsors, sites, and patients in a regulated environment.
Role type
Senior IC Validation Services Analyst (Software Quality Testing)
Builds
Clinical data solutions and validated software applications
Domain
Life Sciences / Clinical Data / Software Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Complex SQL query writing, Data visualization (Tableau/Power BI), SAS applications, Python programming, ETL tools (Informatica), Test automation frameworks, SDLC/Agile/Scrum methodologies, ALM tools (JIRA/Azure DevOps), Data governance concepts, End-to-end testing (Smoke, Integration, System, Regression), RCA and CAPA execution, Test data preparation, Risk assessment
Preferred skills
PL-SQL, PySpark, Snowflake, Cloud-based testing, Web-based SAS platforms, Test automation frameworks, Drug development process knowledge (FDA/GxP/21 CFR Part 11)
Technologies
SQL, Python, SAS, Informatica Power Center, JIRA, Azure DevOps, Confluence, Tableau, Power BI, Snowflake, PySpark
Responsibilities
Write complex SQL queries to conduct data validations and probe quality issues; Perform RCA and CAPA for quality issues and risk assessment; Coordinate creation and execution of automated test scripts; Create and execute manual test scripts using defined validation protocols; Develop and utilize test data sets; Track software versions, features, bugs, and validation efforts; Educate team members on validation standards and SOPs; Collaborate with development and business teams to review project specifications and resolve issues.
Seniority
Senior, hands-on IC
