[Hiring] cGMP Validation & Oracle EBS Quality Assurance Analyst @Leidos

Role Description

Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experience (this experience is a MUST) 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.

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.

Qualifications

• Must hold a minimum of a Bachelor's degree.
• 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.
• Must have 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.

Requirements

• 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.

Benefits

• Pay Range: $59,150.00 - $106,925.00
• The Leidos pay range for this job level is a general guideline only and not a guarantee of compensation or salary.
• Additional factors considered in extending an offer include 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.

Company Description

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.