Software Quality Assurance - Katalyst CRO : Job Details

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• 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 to assure the quality of the deliverables and ensure business needs are met.

Responsibilities

• 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 to assure the quality of the deliverables and ensure business needs are met.

Requirements:

• Strong Validation Resource with 12+ 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 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, 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.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeContract

Job function

• Job functionInformation Technology
• IndustriesPharmaceutical Manufacturing

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