Remote cGMP Oracle EBS QA Specialist | 21 CFR 11

Leidos; United States; Remote; 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 HHS SNS. This role is remote but located in the United States, with a preference for candidates near Atlanta, GA.

The analyst will lead validation and QA activities for Oracle EBS across inventory, supply chain, asset management, and finance, ensuring compliance with cGMP and 21 CFR Part 11 while supporting on-call incident response and 24x7 system availability.

Qualifications

• Bachelor's degree and 5+ years in validation or QA in regulated environments.
• Experience testing Oracle EBS applications.
• Experience with cGMP and 21 CFR Part 11.
• Ability to work on 24x7 on-call support.

Responsibilities

• Lead and support cGMP validation activities for Oracle EBS.
• Develop and maintain validation plans, 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.
• Coordinate validation activities with functional analysts, developers, DBAs, infrastructure engineers, business users, and Government stakeholders.
• Support release-readiness reviews and verify validation evidence before production deployment.

Skills

Oracle EBS testing

cGMP validation

21 CFR Part 11

Validation planning

On-call readiness

Documentation

Education

Bachelor's degree

Tools

Oracle EBS

Job description

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experience to support HHS SNS. This role is remote but located in the United States, with a preference for candidates near Atlanta, GA.

The analyst will lead validation and QA activities for Oracle EBS across inventory, supply chain, asset management, and finance, ensuring compliance with cGMP and 21 CFR Part 11 while supporting on-call incident response and 24x7 system availability.