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One CoreDev IT Inc. (CORE) seeks a Quality Analyst (Solutions Quality Analyst with eCOA) to ensure quality, efficiency, and regulatory compliance of digital life sciences solutions.
You will lead validation documentation, oversee testing activities, and collaborate with project teams to uphold industry standards. The role reports to the Solutions Quality Analyst Team Lead and requires strong analytical skills, attention to detail, and a proactive approach to quality assurance in a dynamic
As a Quality Analyst (Solutions Quality Analyst with eCOA), you will ensure the quality, efficiency, and compliance of digital solutions in life sciences. You will lead validation documentation, oversee testing activities, and collaborate with project teams to maintain industry standards.
This role reports to the Solutions Quality Analyst Team Lead and requires strong analytical skills, attention to detail, and a proactive approach to quality assurance.
Develop and execute validation documentation, including Test Plans, Test Cases, Test Summaries, and Traceability Matrices.
Define test parameters, conduct integration, functional, and stress testing for applications and hardware, and track/report defects.
Coordinate and oversee testing activities, ensuring efficiency and quality while triaging and resolving issues.
Participate in requirements and design reviews, identifying quality gaps and providing timely feedback.
Ensure compliance with industry regulations and Good Clinical Practices in all testing activities.
Generate reports from project management and defect-tracking systems as needed.
Support software design, configuration, and documentation to streamline implementation.
Assist with project milestones, deliverable reviews, and risk mitigation.
Develop and execute UAT documentation (UAT Test sPlans, Scripts, and Summary Reports) and provide support as needed.
Collaborate with copyright/license holders and translation vendors as required.
Perform additional responsibilities as assigned.
3 - 5 years of experience in enterprise software testing, with strong automation testing skills.
Excellent communication, collaboration, and multitasking skills in a dynamic environment.
High school diploma required; Bachelor’s degree in Computer Science, Engineering, or related field preferred.
Experience with eCOA or other clinical trial technologies (ePRO, eConsent, EDC, RTSM, etc.) preferred.
Industry certifications (ISTQB, BBST, TAU, etc.) preferred.