Stephanie W.

Material Operations Technical Specialist @LOTTE Biologics

Syracuse, NY, US

Support CDMO business initiatives including: technology transfers, process improvements, program implementation, facility upgrades and global network projects as required.Support Supply Chain, Warehousing, Dispensary and Cryogenics operations for 4 on-site facilities- Develop, establish and maintain operational processes and improvement projects for Warehouse, Dispensary and Cryogenics departments- Author and review/approve standard operating procedures, work instructions, controlled forms/templates and manufacturing batch records- Author and perform risk assessments as part of the site risk management program- Develop and execute training materials for new processes and equipment in conjunction with the site Technical Training team- Author equipment, facility and process change controls, investigations and CAPA action plans in the Quality Management System- Perform change control impact assessments, respond to audit findings, and perform low risk investigations in the Quality Management System- Work with Supply Chain Planning and Supplier Quality to implement new raw materials and consumables- Interact with cross-functional groups to achieve departmental and organizational goals- Support facility and equipment validation activities- Support Lean OpEx initiatives that align with site strategy- Seek out process inefficiencies and implement solutions- Participate in health authority inspections with direct interaction with inspectors- Adhere to all plant safety policies and procedures and proactively identify unsafe conditions- Certified trainer for the Syracuse site- Use of Microsoft, Veeva, SAP, Maximo and DeltaV programs.

Le Moyne College

Bachelor of Science (B.S.), Biology/Biological Sciences, General