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Senior UAT Lead / Business Analyst With GMP

Seattle, WA

Posted: 03/06/2023 Job Number: 23276510

Job Description

Remote Role.

Project Description:
  • A Senior UAT Lead/ Business Analyst is needed to support Oracle ERP and affiliate system implementations .
  • The UAT Lead is part of the Business Delivery Support Team (BDST) engaging in the global CTDO IT systems including Oracle EBS ERP in support of CTDO late stage clinical and commercial operations.
  • The Business Delivery UAT Lead will work directly with Business Analysts (part of BDST), Business Delivery Leads (BDLs), IT SMEs, site representatives, and other delivery resources to track delivery of all UAT activities to support scalable and compliant delivery of business capabilities within assigned systems.
  • This UAT Lead position focuses on testing end-to-end business processes of system solutions, upgrades, and enhancements, primarily Oracle ERP, and will support non-ERP systems as needed.
  • Responsible for all release deliverables related to User Acceptance Testing .
  • Lead UAT activities including but not limited to planning, execution, defect management, status reporting, summary reporting .
  • Work with Business Delivery Leads to identify business, training, and testing impact, sequence testing (string testing), and assist in identifying what data/ infrastructure is necessary to test.
  • Liaise with system functional validation (SIT/ OQ) team and IT SMEs to understand changes in release .
  • Deliverables: Test Plans, Test Summary Report, Security matrix, Traceability Matrix, requirements, test scripts, test to requirement tracing in HP-ALM, requirement approvals, test approvals, post-execution approvals, defect closure, etc.
  • Understand the project management process and contribute to tracking of individual progress .
  • Oversee the deliverables of the business analysts support team ensuring timelines are met .

Required Skills:
  • 5+ years of experience working in life sciences with detailed FDA Computer System Validation (CSV) experience .
  • Prior User Acceptance Testing experience .
  • Proven awareness of FDA governance concerning computer system validation, regulatory compliance, GMP, GDP, GLP, etc.
  • Understanding of training qualifications for validation participation .
  • Strong Attention to detail; excellent communication skills, pro-active, good organization skills, follow-through .
  • Ability to work independently and cooperatively in a diverse group .
  • Experienced in business analysis processes including requirements gathering, requirements documentation, process flow charts, requirements traceability, UAT, etc.
  • Strong working knowledge of MS Word, Excel, and Project Management tools .
  • Desire and ability to learn new software and applications quickly .
  • Demonstrate the ability to work in a high pace and frequently shifting environment .
  • HP-ALM or electronic testing system experience .
  • Understanding of fundamentals of Systems Development Life Cycle and Waterfall/Agile methodologies.
  • Experience in supporting major system implementations/ deployment .

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Malika: malika@alphaconsulting.Com


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Malika Peguero

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