cGMP Validation & Oracle EBS Quality Assurance Analyst

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

Description

Leidos is seeking an experienced cGMP Validation Quality Assurance Analystwith strong Oracle EBS testing experience to support the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Strategic National Stockpile (SNS).

Contingent upon contract award

Candidate MUST:

Be a US Citizen or Green Card holder with the ability to obtain a Public Trust Clearance.

Role is remote but MUST be located in the UNITED STATES

preference for candidates who are local to the Atlanta, GA area

Position Summary

The successful candidate will support validation and quality assurance for mission-critical Oracle E-Business Suite (EBS) systems supporting inventory, supply chain, asset management, financial, and warehouse operations.

The analyst will ensure system changes meet applicable cGMP, 21 CFR Part 11, HHS, SNS, and system-development requirements while planning and executing functional, integration, regression, and user acceptance testing for Oracle EBS applications.

The SNS mission depends on 24x7 availability of systems that support the nation's emergency medical supply readiness and public health response. This position will participate in on-call services and must be able to acknowledge critical incidents within 15 minutes while on call.

Primary 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.

Basic Qualifications

• 5+ years of experience in computerized-system validation, software quality assurance/testing, or related regulated-system activities, including substantial cGMP validation experience.
• Demonstrated experience with cGMP computerized-system validation in a regulated environment.
• Working knowledge of 21 CFR Part 11 and validation/change-control principles.
• Experience developing validation plans, protocols, traceability matrices, test scripts, validation evidence, deviation documentation, and summary reports.
• Experience testing Oracle E-Business Suite (EBS) applications.
• Experience with functional, integration, regression, and user acceptance testing.
• Experience translating requirements, user stories, and acceptance criteria into executable test scenarios and scripts.
• Experience documenting, tracking, retesting, and closing defects and validation deviations.
• Strong documentation, analytical, communication, and organizational skills.
• Ability to work effectively with business, functional, development, infrastructure, and Government stakeholders.
• Ability to obtain and maintain the required Tier 2 background investigation/security eligibility and comply with HHS/ASPR/SNS security and training requirements.
• Ability to participate in 24x7 on-call support and respond to mission alerts within required timeframes.

Preferred Qualifications

• Experience validating Oracle EBS R12 applications.
• Experience supporting Oracle EBS supply-chain, inventory, warehouse, asset-management, or financial modules.
• Experience with FDA-regulated, pharmaceutical, medical-device, medical-supply, public-health, or other cGMP environments.
• Experience incorporating validation evidence into Agile/SAFe delivery.
• Experience with automated testing or test-management tools.
• Experience with Oracle EBS hosted in Oracle Cloud Infrastructure (OCI).
• Familiarity with HHS EPLC or other federal system-development/governance frameworks.

If you're looking for comfort, keep scrolling. At Leidos, we outthink, outbuild, and outpace the status quo - because the mission demands it. We're not hiring followers. We're recruiting the ones who disrupt, provoke, and refuse to fail. Step 10 is ancient history. We're already at step 30 - and moving faster than anyone else dares.

Pay Range: Pay Range $59,150.00 - $106,925.00

The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

About Leidos

Leidos is an industry and technology leader serving government and commercial customers with smarter, more efficient digital and mission innovations. Headquartered in Reston, Virginia, with 47,000 global employees, Leidos reported annual revenues of approximately $16.7 billion for the fiscal year ended January 3, 2025. For more information, visit www.Leidos.com.

Pay and Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available at www.leidos.com/careers/pay-benefits.

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.