Senior Software Quality Assurance Engineer Job at United Pharma Technologies Inc, Chicago, IL

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  • United Pharma Technologies Inc
  • Chicago, IL

Job Description

Job Title: Senior Software Quality Assurance (SQA)

Location: Chicago, IL

Job Overview:

We are seeking a Senior Software Quality Assurance (SQA) professional to join our team. The ideal candidate will have extensive experience in Software Quality Assurance (SQA) with a focus on reviewing and approving SDLC deliverables. This role requires expertise in SDLC validation, risk assessments, and the ability to collaborate with cross-functional teams to ensure the successful implementation of regulated IT applications. The candidate will ensure compliance with applicable standards and help build quality in deliverables.

Responsibilities:

  • Oversee Software Quality Assurance processes with review and approval experience for SDLC deliverables.
  • Provide experience with SDLC/Software Validation, including the writing and execution of SDLC deliverables such as MVP testing.
  • Conduct assessments (e.g., FMEA), create and review requirements, IQ, OQ, PQ, trace matrices, and system releases.
  • Review and approve SDLC deliverables including MVP, Risk Assessments (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and write System Certifications.
  • Support SQA review, approval, and implementation of regulated IT applications.
  • Collaborate with development teams to ensure compliance and maintain quality in deliverables that meet business needs.

About You:

  • 8+ years of strong validation experience in SQA.
  • Ensure IT validation packages are inspection-ready and in compliance with company policies and procedures.
  • Experience with automated testing and implementation.
  • Proficient in understanding GxP regulations and validation principles.
  • Experienced in reviewing CAPA’s, Change Control, and Defects in relation to Software Validation.
  • Familiar with various applications/tools such as JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, and other continuous integration tools.
  • Understanding of both Waterfall and Agile software development methodologies.
  • Authorized to work in the United States for any employer or possess proper documentation if associated with a third-party agency.
  • Must pass background and reference checks.

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