cGMP Validation & Oracle EBS Quality Assurance Analyst

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

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.