The Leidos Health group is currently looking for a Quality Assurance Specialist / Software Test Engineer with experience verifying and validating software solution governed by cGMP requirements. Experience with Oracle EBS Application is a must. The project supports a critical national security mission. You will certainly find purpose with your work.
The successful candidate will serve as the cGMP Quality & Validation Specialist supporting a re-implementation of an existing on-premise Oracle ERP installation to Oracle Cloud Infrastructure. The Oracle EBS is a large, complex Financial and Supply Chain implementation supporting Department of Human and Health Services. The project will cover, among other areas, Project Management, Technical architecture and cloud infrastructure, Core ERP implementation, Analytics and business intelligence configuration, Data migration, Warehouse interface implementation, and Current Good Manufacturing Practices (cGMP) validation. You will be a key contributor to ensure the Oracle EBS based product meet the functional requirement specifications and cGMP requirements. Ultimately, our team reduces costs and supports innovation to streamline the financial and supply chain operations of a critical public health mission. The candidate can be located anywhere in the U.S. with no travel expected but must be able to work during Eastern Time Zone.
EDUCATION & EXPERIENCE:
- A Bachelor’s degree and 5 years of software testing experience and 3 years in Oracle eBusiness Suite
- 3 or more years of cGMP experience for validation of computer systems in a pharmaceutical company or in a computer validation company
- Good knowledge of
- 21 CFR Part 11 Electronic Records and Electronic Signature
- 21 CFR Part 820 Quality Management system
- 21 CFR Part 210 & 211Good Manufacturing Practices
- Knowledge of validation based on SDLC (System Development Life Cycle)
- Knowledge of Good Documentation Practices
- Knowledge of Change Management
- Has experience of developing and executing test scripts and other validation documents such as Functional Requirement Specifications and Traceability Matrix.
- Designing test strategies, test plans, and test cases from requirements, design documents and specifications
- Execution of test cases including functional, regression, performance, load and smoke tests
- Ensure cGMP compliance with the quality assurance and change management process
- Reporting, tracking, validating and closing defects
- Experience with Oracle EBS R12
- Able to obtain Public Trust
Preferred qualifications include:
- Relevant cGMP and/or Oracle certifications
- Experience working with any federal government agencies
Pay Range:Pay Range $65,000.00 - $100,000.00 - $135,000.00
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 (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.
Leidos is a Fortune 500® technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, civil, and health markets. The company’s 47,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $14.4 billion for the fiscal year ended December 30, 2022. For more information, visit www.Leidos.com.
Pay and Benefits
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