QA Analyst II

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How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.This position is located in Lincoln, Nebraska. Set-up and manage system upgrade for the SPC Infinity software. Expand the use of Infinity across the site and provide BU support to integrate SPC methodologies into their manufacturing processes. Value map and streamline processes using Six Sigma / Lean principles. Lead continuous improvement projects and leverage the use of Sharepoint to create defined, standardized, robust processes. Drive process control initiatives Perform data analysis to support investigations or process improvements. Familiar with Mini-tab or equivalent statistical software. Lead root cause analysis investigations. Review and approve equipment qualification and process validation. Identify and implement better validation approaches and utilize FMEA, DOE, process capability and other improvement tools. Review change controls, specifications, test methods, validation protocols, equipment qualifications, validation reports, and other documents to ensure cGMP compliance. Develop and implement quality dashboards that communicate key quality metrics across the site. Utilize web based tools and data analysis techniques that provide real-time feedback.QualificationsMinimum: " Bachelor s degree in engineering, computer science or relevant field." Through knowledge of cGMPs and FDA regulatory requirements" Strong working knowledge of pharmaceutical processes and those manufacturing processes associated with APIs, raw materials, and packaging components." Excellent communication and interpersonal skills (oral and written)." 5-7 years of relevant experiencePreferred:" Trained in Greenbelt, Blackbelt, or similar Six Sigma methodology" Demonstrate a high level of computer aptitude. Strong familiarity with database design. Programming skills in Visual Basic, VB.NET, or equivalent.
Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here