Senior Software QA/Validation Engineer-Chicago, IL

Title: Senior Software QA/Validation Engineer

Location: Chicago, IL

Duration: 12 Months+ with very likely extension.

2 references need to be provided at time of profile submission from previous two projects.

You will be responsible for:

• Software Quality Assurance with Review and Approval Experience for SDLC Deliverables
• Experience should have earlier in career in SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP testing)
• Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release).
• Several years of SQA experience with Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification)
• Support as SQA in the Review and Approval and implementation of regulated IT applications.
• Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.

About you:

• Strong Validation Resource with 7+ yrs Experience
• Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
• Previous experience with automated testing and implementation.
• Proficient in understanding of GxP regulations and validation principles
• Good experience in Review of CAPA's, Change Control and Defects as it applies to Software Validation
• Familiarity with a range of applications/tools including JIRA, Confluence, Client-ALM, Tosca, Confluence, Veera ,Qtest, M-Files, or other continuous integration tools
• Knows the difference between Waterfall and Agile software development methodologies
• Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency
• Must pass background and reference checks

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