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Job Details

QA Operations Specialist


Security Operations


Millburn, New Jersey, United States

236 million lives were touched by Novartis medicines in 2022, 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><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>The QA Operations Specialist is responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems.<br><br>Your responsibilities include, but are not limited to: <br><br>• Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.<br>• Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately. <br>• Assist functional areas with achieving timely and compliant final product disposition of the product.<br>• Review, approve and support procedures and production/testing records as required and assist in the training of site associates. <br>• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.<br>• Support FDA/Regulatory interactions for the site activities and products to ensure successful regulatory submissions and inspections.<br>• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.<br>• Other related duties as assigned.<br>Additional Specifications <br>• This position involves shift work which will be defined through site start up and commercialization readiness. <br>• This position involves on-call shifts, if required, when scheduled. <br><br>Note: Schedule: Wednesday - Saturday 1st Shift<br><br>The pay range for this position at commencement of employment is expected to be between $88,000.00 and $132,000.00 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.<br><br>[#video#{#400,300#}#/video#]