Responsibilities:
- CAPA: Lead event investigations using root cause problem-solving tools. Write and obtain approval for investigation reports to meet timeliness goals and production schedule. Manage corrective action deliverables for timely completion. Interface with Manufacturing batch record review and Quality to address batch record errors. Develop and implement Right The First Time and Human Error Reduction initiatives.
- Track and report metrics.
- Training: Develop and implement Training Excellence initiatives and use ISOtrain to assign appropriate training curriculum. Conduct general awareness training. Monitor training compliance to reduce/eliminate missed training. Interface with site training coordinator; track and report metrics.
- Documentation: Improve and update directions with cross-functional teams; interface with Documentation Center personnel to revise documents.
- Inventory maintenance and production tracking: SAP subject matter expert for inventory and production. Track and report bulk usages. Support production in inventory management. Interface with Planning to create/manage production process order numbers and batch numbers. Initiate/track blanket purchase orders for goods and services. Track weekly/monthly yield performance and report to Department supervision and Finance.
Qualifications:
- BS degree in Engineering or Science (preferred).
- 5+ yearsβ experience in pharmaceutical/biological/chemical manufacturing (preferred).
- Strong working knowledge of Microsoft Office and communications software packages.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.