QA Operations Specialist (2nd shift)

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. <br>We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!<br>Imagine what you could do here at Novartis!<br><br>The Quality Assurance Specialist will be responsible for oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations, Advanced Accelerator Applications procedures and systems.<br><br>o Support continuous improvement of quality systems and policies for production, engineering, and supply chain according to Advanced Accelerator Applications Global Quality Standards, applicable local and global regulatory requirements, and registered Product information.<br>o Provide QA support of production, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, C of As (as applicable), CAPAs, Deviations, change controls, and shop floor oversight. Provides the production, engineering, and supply chain teams with QA/Compliance guidance and decisions.<br>o Review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, engineering and supply chain.<br>o Build collaborative interfaces with all stakeholders to ensure quality systems such as deviation management, investigations, corrective and preventive actions, and change controls are in place and followed.<br>o Support/assist in development of the training program QA operations associates which include shop floor programs and training curricula, batch record review and release, and the validation program training curriculum as well as operational quality systems and compliance.<br>o Support continuous quality improvement program for manufacturing operations and partner with the production, engineering, and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed<br><br>WORK SCHEDULE: <br>2nd shift Sunday - Wednesday OR Wednesday - Saturday; shift hours 1:00 pm - 11:00 pm (4x10)<br><br>https://www.youtube.com/watch?v=lhJ9KXNWhEI