cGMP Validation & Oracle EBS Quality Assurance Analyst

Description

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experienceto 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.

• 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.

• 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.