Identify and lead continuous process improvement initiatives that improve the customer experience, enhance workflow, business and manufacturing processes and/or improve the work environment; Liaise with early discovery and development partners to drive the continuous flow of knowledge from manufacturing to early research speeding development and reducing time to market for new products; Organize and oversee management of Quality principles for SPC, Quality-by-Design (QBD), Quality Control, Test Method and Process Validation, Tech Transfer and stability teams, including the review and approval of protocols and reports; Foster a strong QBD culture striving for continuous quality improvement throughout the entire company; Engage in driving the quantitative assessment of specification setting, release limits, process monitoring metrics, and risk assessments
A minimum of a master’s degree in statistics, genetics, or related field is required, Advanced Degree preferred; Minimum of 0-5 years experience in one or more of the following areas is required: quality, regulatory, laboratory experience, statistics, six-sigma, engineering; Knowledge of biology, genetics, familiarity with genomic data, proficiency in molecular techniques, NGS preferred; Working knowledge of cGMP/CFR/FDA regulations, with knowledge of Out of USA regulations; Experience with applicable FDA regulations and ISO standards, working knowledge of international regulations strongly preferred
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