Sotera Health, LLC

Opportunity to learn how to perform audits and reviews over internal controls as part of our company's internal audit function.

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

As a member of the IT Security, Governance and Service Delivery team you will actively work with the Global IT team and other business partners. The position is responsible for participating in or leading the investigations, mitigation and resolution of information security events, alerts and incidents, performing security vulnerability and risk assessments, monitoring and measuring information security compliance, defining security requirements for various IT projects and testing and validation of security controls.