cGMP Validation, Oracle EBS Quality Assurance Analyst

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and assist in the validation of computerized systems in compliance with cGMP for Oracle EBS applications and their enhancements.

• Create and uphold validation plans, requirements traceability, test protocols/scripts, validation evidence, deviation records, and summary documentation related to validation.

• Ensure that system modifications adhere to relevant cGMP standards, 21 CFR Part 11, SNS change-control policies, and validation criteria.

• Incorporate validation tasks and documentation into Agile development cycles and release procedures.

• Evaluate requirements, user stories, acceptance criteria, functional designs, configurations, and changes for their testability and impact on validation.

• Design and implement test plans, scenarios, scripts, and cases for functional, integration, regression, and user acceptance testing of Oracle EBS.

• Record test outcomes, defects, deviations, corrective actions, and evidence of retesting.

• Validate changes in Oracle EBS related to inventory, warehouse, supply chain, asset management, and financial processes.

• Coordinate validation and testing efforts with functional analysts, developers, DBAs, infrastructure engineers, business users, and Government stakeholders.

• Assist in release-readiness evaluations and confirm that necessary validation and testing documentation is in place prior to production deployment.

• Maintain validation and quality assurance documentation according to configuration and document control standards.

• Aid in audits, assessments, and requests for validation documentation.

• Engage in Agile planning, refinement, demonstrations, and retrospectives as needed.

• Support critical system issues and emergency response initiatives as required by the SNS mission.

• Acknowledge critical incidents within a 15-minute window while on-call.

⛳️ Requirements

• Over 5 years of experience in computerized system validation, software quality assurance/testing, or similar regulated-system activities, with significant cGMP validation expertise.

• Proven experience in cGMP computerized system validation within a regulated setting.

• Proficient understanding of 21 CFR Part 11 and principles of validation/change control.

• Experience in developing validation plans, protocols, traceability matrices, test scripts, validation evidence, deviation records, and summary reports.

• Familiarity with testing Oracle E-Business Suite (EBS) applications.

• Experience conducting functional, integration, regression, and user acceptance testing.

• Ability to convert requirements, user stories, and acceptance criteria into actionable test scenarios and scripts.

• Experience in documenting, tracking, retesting, and resolving defects and validation deviations.

• Strong skills in documentation, analysis, communication, and organization.

• Capability to effectively collaborate with business, functional, development, infrastructure, and government stakeholders.

• Must be able to obtain and maintain the necessary Tier 2 background investigation/security eligibility.

• Must comply with HHS/ASPR/SNS security and training requirements.

• Must be available for 24x7 on-call support and respond to mission alerts within specified timeframes.

• Preferred: Experience in validating Oracle EBS R12 applications.

• Preferred: Experience in supporting Oracle EBS modules related to supply chain, inventory, warehouse, asset management, or finance.

• Preferred: Experience within FDA-regulated, pharmaceutical, medical device, medical supply, public health, or other cGMP environments.

• Preferred: Experience in integrating validation evidence into Agile/SAFe delivery methodologies.

• Preferred: Familiarity with automated testing or test management tools.

• Preferred: Experience with Oracle EBS hosted on Oracle Cloud Infrastructure (OCI).

• Preferred: Knowledge of HHS EPLC or other federal system development/governance frameworks.

• Must be a US Citizen or Green Card holder capable of obtaining a Public Trust Clearance.

🏝️ Benefits

• Flexible remote work arrangement.

• Participation in 24x7 on-call services.

• Opportunity to contribute to mission-critical public health and emergency response systems.