Summary:Provide validation and testing services to ensure system integrity, data accuracy, and regulatory compliance for Poseida integration initiatives. Support validation activities across QMS migration, archival systems, and reporting platforms within a regulated Life Sciences environment.
Roles & Responsibilities: - Validation & Testing
- Design, develop, and execute validation strategies, test plans, and test cases
- Perform functional, integration, and data validation testing for enterprise systems
- Validate Tableau reporting outputs and eArchive system integrations
- Verify metadata accuracy and completeness during QMS migration activities
- Ensure archival integrity, traceability, and compliance of migrated records
- Compliance & Data Integrity
- Support CSV (Computer System Validation) activities and documentation
- Ensure compliance with ALCOA+ data integrity principles and regulatory standards
- Assist in validation lifecycle activities including execution evidence and defect tracking
- Collaborate with QA and compliance teams to address validation findings and remediation activities
Coordination & Reporting - Work closely with business, QA, and technical teams during testing and validation cycles
- Prepare validation summaries, execution reports, and compliance documentation
- Support issue resolution, retesting, and final sign-off activities
- Validation strategy and test plans
- Test execution and defect reports
- Data and metadata validation reports
- Archival verification documentation
- Final validation summary reports
Education & Experience: - 10+ years of experience in validation and testing within Life Sciences or regulated environments
- Strong experience in Clinical Data Validation and QMS validation processes
- Experience supporting CSV activities and regulatory compliance initiatives
- Knowledge of ALCOA+ principles, data integrity standards, and validation methodologies
- Hands-on experience validating Tableau reports and archival/eArchive systems
- Strong analytical, documentation, and stakeholder communication skills
- Experience with QMS migration and metadata validation
- Familiarity with Life Sciences compliance standards and GxP environments
- Exposure to enterprise archival systems and regulatory audit support
