Senior Quality Engineer

November 7

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Description

• The Senior Quality Engineer is responsible for facilitating full investigation of deviations and non-compliance issues encountered during pharmaceutical processing, handling and operation. • This position will also oversee the review of corrective and preventative action (CAPA) plans to assure completion. • This position also requires review and approval of protocols and associated documents. • This position supports the site Product Scorecard program by serving as a Subject Matter Expert (SME) on Statistical Analysis and product trending.

Requirements

• Bachelor’s degree in Engineering, Science, or related discipline with a minimum of 5-8 years’ relevant experience OR Master’s degree in above disciplines with a minimum of 3-6 years’ relevant experience OR PhD with a minimum of 0-3 years’ relevant experience. • Must possess a solid background in statistical analysis; demonstrate proficiency with use of statistical software such as JMP, Minitab, etc. • Thorough knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping, statistical process control, design of experiments, and other related engineering tools. • Requires an individual well versed in cGMPs; floor operations; solid understanding of manufacturing operation.