The Senior Quality Engineer will support manufacturing quality assurance in the manufacturing, packaging, product release, and related systems. The position supports new quality system/methodologies implementation, training, and problem solving, including leading non-conformance investigations, root cause analysis, and development of corrective and preventive actions.
This position will work directly with Manufacturing, Engineering, Quality Control, and other Senior Quality Engineers to provide sustaining quality and compliance leadership. It is responsible for trending key quality metrics to drive quality, continuous improvement, and efficiency.
BS in Engineering, Chemistry, Biology, or related field. A combination of education and experience will be considered.
Special Skills: Quality Engineering training in statistics, validation, and working knowledge of compounding, filling (aseptic / non-sterile) and packaging processes within the pharmaceutical industry.
Ability to work independently. Ability to communicate and work well with others. Knowledge of sampling plans (e.g. Mil standard) and GxP compliance requirements. Six Sigma training and ASQ certification preferred.