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Creative Testing Solutions · 2 months ago

IT Quality Assurance Manager

United States

Full-time

Remote

Senior Level

5+ years exp

Creative Testing Solutions is responsible for quality oversight of GMP IT systems. The IT Quality Assurance Manager will oversee quality execution of the lifecycle, benchmarking, and quality measures enhancement of software applications and IT quality services in an evolving laboratory business.

Health CareHealth DiagnosticsNon ProfitProfessional Services

Responsibilities

Collaborate with IT service management, project managers, software developers, application and system administrators, application support, and other stakeholders to identify and resolve quality issues and operational risks associated with software applications, IT projects and changes

Ensure changes to GMP software and IT services are performed according to CTS standards through QA review and approval of change records, active participation in the Change Advisory Board, and on project teams as needed

Ensure thorough testing of GMP software applications and IT services, including functional, regression, and performance testing such that systems are validated for their intended use and meet current GMP standards

Proactively assist IT in the development, implementation, and maintenance of procedures for IT systems and software applications so that they appropriately reduce quality and compliance risk

Review and approve standard operating procedures, protocols, and change records for the administration, validation and operation of computerized systems within a GMP environment

Assist with root cause analysis and CAPA implementation in errors that involve GMP software applications and IT services

Continuously improve QA methodologies and tools associated with SDLC oversight, based on lessons learned and evolving standards within industry best practices and the GMP environment

Create and/or execute end user test plans, test cases, and test scripts that meet GMP standards

Ensure software and IT services management and use follows industry standards, GMP regulations, and best practices

Have a thorough understanding of subject matter in area of responsibility and act as a resource

Maintain systems in areas of responsibility and ensure system output meets current requirements in a manner compliant with laboratory quality standards and current regulatory guidelines

Evolve as part of continuous improvement to cultivate change and innovation

Champion OE culture within areas of responsibility

Actively build relationships to influence and collaborate cross functionally

Perform all assigned duties in compliance with CTS policies and procedures. Bring compliance issues to the attention of management

Perform all other duties, at the discretion of management, as assigned

Qualification

GMP regulations expertiseQA programs proficiencySDLC methodologies knowledgeQuality risk reduction toolsEnterprise QMS softwareAutomated testing frameworksAgileScrum familiarityAnalytical skillsAttention to detailCommunication skillsCollaboration abilities

Required

Education: Bachelor's degree in computer science, life science or other related area required

Experience: A minimum of five (5) years of QA experience in software and IT services management within a GMP environment required

Subject matter expertise in the application of GMP regulations to software development and configuration (e.g., FDA 21 CFR Part 11, EMA Annex 11 and 22, data integrity, GAMP, computer systems validation)

Demonstrated proficiency with QA programs, systems and procedures including quality benchmarking, risk management, continuous improvement programs and industry specific regulations

Demonstrated knowledge in software development life cycle (SDLC) methodologies

Familiarity with IT industry standards (e.g., ITIL, COBIT, ISO/IEC 12207, 90003 and/or 25010)

Experience with using quality risk reduction tools (e.g., FTA, FMEA, VOC and CTQ, HACCP)

Experience and proficiency in use of enterprise QMS software, IT service management software, and automated software testing tools