Remote cGMP Validation QA Analyst - Oracle EBS

Leidos Inc; Atlanta (GA); 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 the U.S. Department of Health and Human Services (HHS), ASPR, SNS.

The successful candidate will support validation and quality assurance for Oracle E-Business Suite (EBS) systems across inventory, supply chain, asset management, financial, and warehouse operations, ensuring changes meet cGMP, 21 CFR Part 11, SNS, and development requirements while planning and

Qualifications

• 5+ years of validated testing in regulated environments including cGMP validation.
• Experience testing Oracle E-Business Suite (EBS).
• Knowledge of 21 CFR Part 11 and validation/change-control principles.
• Experience developing validation plans, protocols, traceability matrices, and test scripts.

Responsibilities

• Lead and support cGMP computerized-system validation activities for Oracle EBS applications and enhancements.
• Develop and maintain validation plans, traceability, test protocols/scripts, validation evidence, deviation records, and validation summary documentation.
• Ensure changes comply with cGMP, 21 CFR Part 11, SNS change-control, and validation requirements.
• Coordinate validation and testing with analysts, developers, DBAs, infrastructure engineers, business users, and Government stakeholders.
• Support audits, assessments, and requests for validation evidence.
• Participate in Agile planning and reviews as appropriate.

Skills

cGMP validation

Oracle EBS

21 CFR Part 11

QA testing

Agile testing

Job description

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experience to support the U.S. Department of Health and Human Services (HHS), ASPR, SNS.

The successful candidate will support validation and quality assurance for Oracle E-Business Suite (EBS) systems across inventory, supply chain, asset management, financial, and warehouse operations, ensuring changes meet cGMP, 21 CFR Part 11, SNS, and development requirements while planning and