Remote cGMP Validation & Oracle EBS QA Analyst

Leidos Inc; Reston (VA); Remote; USD 59,000 - 107,000; Full time

Job summary

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle E-Business Suite (EBS) testing experience to support HHS SNS. The role is remote within the United States, with a preference for candidates near Atlanta, GA, and requires US citizenship or Green Card with the ability to obtain a Public Trust Clearance.

The successful candidate will validate Oracle EBS systems across inventory, supply chain, asset management, financial, and warehouse operations, ensuring

Qualifications

• Bachelor's degree required with 5+ years in computerized-system validation or related regulated activities.
• Demonstrated experience with cGMP computerized-system validation in a regulated environment.
• Must have experience testing Oracle E-Business Suite (EBS) applications.
• Experience with functional, integration, regression, and user acceptance testing.
• Ability to translate requirements into executable test scenarios and scripts.
• Strong documentation, analytical, communication, and organizational skills.

Responsibilities

• Lead and support cGMP validation activities for Oracle EBS applications and enhancements.
• Develop and maintain validation plans, requirements traceability, test protocols/scripts, validation evidence, deviation records, and validation summaries.
• Ensure changes comply with cGMP, 21 CFR Part 11, SNS change-control, and validation requirements.
• Coordinate validation activities with analysts, developers, DBAs, infrastructure engineers, business users, and Government stakeholders.
• Develop and execute test plans, scenarios, scripts, and cases for Oracle EBS functional, integration, regression, and UAT testing.
• Document test results, defects, deviations, corrective actions, and retesting evidence.
• Support release-readiness reviews and validation evidence before production implementation.
• Maintain validation and QA documentation per configuration and document-control requirements.

Skills

Oracle EBS testing

cGMP validation

QA testing

UAT testing

Agile testing

Documentation

Education

Bachelor's degree

Tools

Oracle EBS

OCI

Job description

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle E-Business Suite (EBS) testing experience to support HHS SNS. The role is remote within the United States, with a preference for candidates near Atlanta, GA, and requires US citizenship or Green Card with the ability to obtain a Public Trust Clearance.

The successful candidate will validate Oracle EBS systems across inventory, supply chain, asset management, financial, and warehouse operations, ensuring