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QA Operations Specialist (2nd Shift)


Security Operations


Millburn, New Jersey, United States

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, AAA procedures and systems.<br><br>Your responsibilities include, but are not limited to:<br><br>Ensure harmonization of QA practice at the NJ site concerning quality issues and keep the quality standard policy up to date according to Corporate, ICH, GMP & FDA guidelines<br>• Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to cGMP<br>• Responsible for authoring, revising and approving standard operating procedures, policies and records<br>• Ensure facility, equipment’s and software’s are properly qualified and validated for GMP use.<br>• Ensure Cleaning, Testing and Manufacturing processes are properly validated.<br>• Daily review of manufacturing batch records for product release. This includes conducting independent technical review of documentation post-execution of cGMP activities. Ensure all specifications are met and that applicable requirements are completed and acceptable.<br>• Ensure OOS, deviation, change control processes are properly followed, provide QA decisions and approval for these exceptions. Ensure that investigation determine root cause, impact assessment and appropriate preventative/corrective actions. Ensure timely closure of investigations, and proper escalation to management as per local and global procedures.<br>• Responsible for product disposition decision.<br>• Monitor QA process and manage communication and reporting according to a defined frequency<br>• Support employee training to diffuse new regulations and policies<br>• Participate in Quality Product Review<br>• Perform an annual product review<br>• Collaborate with other departments to create/review risk assessments<br>• Supports audit and inspection as required.<br><br>4 days/week 2nd Shift -Thursday -Sunday 1P start time<br><br>[#video#{#400,300#}#/video#]