Remote cGMP Validation & Oracle EBS QA Lead

Quest Oracle Community; Atlanta, Northern (GA, KY); Hybrid; USD 59,000 - 107,000; Full time

Job summary

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experience to support the SNS for ASPR/HHS. The role is remote and located in the United States, with local preference for Atlanta, GA.

The candidate will lead validation activities across Oracle EBS modules, ensure compliance with 21 CFR Part 11 and cGMP requirements, and participate in 24x7 on-call support for mission-critical systems involved in national health readiness.

Qualifications

• 5+ years of computerized-system validation, software quality assurance/testing, or related regulated-system activities.
• Demonstrated experience with cGMP validation in a regulated environment.
• Working knowledge of 21 CFR Part 11 and validation/change-control principles.
• Experience testing Oracle E-Business Suite (EBS) applications.
• Experience translating requirements into executable test scenarios and scripts.

Responsibilities

• Lead and support cGMP computerized-system validation activities for Oracle EBS applications and enhancements.
• Develop and maintain validation plans, requirements traceability, test protocols/scripts, validation evidence, deviation records, and validation summary documentation.
• Ensure system changes comply with applicable cGMP, 21 CFR Part 11, SNS change-control, and validation requirements.
• Integrate validation activities and evidence into Agile development iterations and release processes.
• Review requirements, user stories, acceptance criteria, functional designs, configurations, and changes for testability and validation impact.
• Develop and execute test plans, scenarios, scripts, and cases for Oracle EBS functional, integration, regression, and user acceptance testing.
• Document test results, defects, deviations, corrective actions, and retesting evidence.
• Validate Oracle EBS changes across applicable inventory, warehouse, supply-chain, asset-management, and financial processes.
• Coordinate validation and testing with functional analysts, developers, DBAs, infrastructure engineers, business users, and Government stakeholders.
• Support release-readiness reviews and verify required validation and testing evidence before production implementation.
• Maintain validation and QA documentation in accordance with configuration and document-control requirements.
• Support audits, assessments, and requests for validation evidence.
• Participate in Agile planning, refinement, demonstrations, and retrospectives as appropriate.
• Support critical system issues and emergency-response activities as required by the SNS mission.

Skills

Oracle EBS testing

cGMP validation

QA testing

UAT testing

Job description

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experience to support the SNS for ASPR/HHS. The role is remote and located in the United States, with local preference for Atlanta, GA.

The candidate will lead validation activities across Oracle EBS modules, ensure compliance with 21 CFR Part 11 and cGMP requirements, and participate in 24x7 on-call support for mission-critical systems involved in national health readiness.