Software Quality Engineer

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Join to apply for the Software Quality Engineer role at Katalyst CRO . Review and approve software lifecycle (SLC) deliverables for regulated applications, including risk classifications, requirements, configuration/design specs, IQ, OQ, PQ, trace matrix, and summary reports. Collaborate with cross-functional teams to build compliance capabilities, ensuring the quality of deliverables and meeting business needs. Review CAPAs, change controls, and defects for GxP applications. Work with global teams and provide audit support. Utilize applications/tools such as ALM, TrackWise, JIRA, Confluence, and other integration tools. Responsibilities Review and approve software lifecycle (SLC) deliverables for regulated applications. Collaborate with teams to ensure compliance and quality. Review CAPAs, change controls, and defects. Support audits with global teams. Work with various applications/tools including ALM, TrackWise, JIRA, and Confluence. Requirements Bachelor's degree with 8+ years of experience or Master's with 5+ years preferred. Experience in regulated industries with GxP systems. Knowledge of FDA regulations such as 21 CFR Part 11, 820, Annex 11, GAMP5, ISO 13485, ISO 27001. Familiarity with quality and test management tools like TrackWise, ComplianceWire, Veeva, ALM, JIRA. Understanding of Data Integrity and audit support experience. Experience with SaaS, IaaS, PaaS, COTS, and custom applications. Seniority level Mid-Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing This job is active and accepting applications. #J-18808-Ljbffr
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Location:
Irving, TX, United States
Category:
Computer And Mathematical Occupations

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