The purpose of the position is to lead and manage the engineering services compliance metrics including non-conformances, CAPAs, work orders, training, and safety. This position will be the liaison between engineering services and quality.
1. Lead the monthly compliance metrics meeting focusing on non-conformances, CAPAs, work orders, training, SOP 3 year reviews, and safety.
2. Responsible for on-time performance of engineering services compliance metrics.
3. Performs technical investigations for engineering services non-conformances with root cause analysis and solid CAPA management to prevent reoccurrence.
4. Approves GxP documentation for project implementation.
5. Lead / participate in cross functional teams for investigations, CAPAs, WOs, and safety projects and issue meeting minutes.
BS in Engineering or related field.
Special Skills: Quality Engineering training in statistics, validation, and thorough 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 preferred.