Sotera Health, LLC

Working in the regulated life sciences industry with GAMP5/21 CFR Part 11 and other global equivalent regulatory requirements, the Quality Assurance Analyst is responsible for supporting IT projects, service teams, and management in the quality aspects of implementation and maintenance of qualified/validated computer systems. The IT QA Analyst will be responsible for participating in IT quality control activities such as, Testing plan development, risk assessments, evaluation testing, periodic reviews and execution for IT-related initiatives and activities Development and completion of IQ/OQ documentation for IT-related initiative activities, Development of Policies and ProceduresInterfacing with QA departments to clearly define the IT quality-related role and requirements in Projects, initiatives, and operational activitiesFacilitating periodic controls assurance activities, including but not limited to, periodic access reviews and system configuration and change management evidence collection

Working in the regulated life sciences industry with GAMP5/21 CFR Part 11 and other global equivalent regulatory requirements, the Quality Assurance Analyst is responsible for supporting IT projects, service teams, and management in the quality aspects of implementation and maintenance of qualified/validated computer systems. The IT QA Analyst will be responsible for participating in IT quality control activities such as, Testing plan development, risk assessments, evaluation testing, periodic reviews and execution for IT-related initiatives and activities Development and completion of IQ/OQ documentation for IT-related initiative activities, Development of Policies and ProceduresInterfacing with QA departments to clearly define the IT quality-related role and requirements in Projects, initiatives, and operational activitiesFacilitating periodic controls assurance activities, including but not limited to, periodic access reviews and system configuration and change management evidence collection