Principle QA Specialist - IT

Job description

Working within the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and compliant. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal company policies and procedures. As a Principal QA Specialist, a typical day might include the following: Supporting IT related change controls, CAPAs, data integrity initiatives, deviations, internal and external audits and other verticals to ensure a robust, compliant state of programs Engaging with Corporate and IOPS IT ensuring IT processes and procedures meet Regeneron’s Quality System requirements Reviewing, editing and approving SOPs, deviation notifications, deviation investigations, and corrective actions Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Collaborating, investigating and troubleshooting to determine solutions or recommendations for changes and/or improvements Participating and supporting the Quality Risk Management (QRM) principles in the for...