Sean Lee's Email Addresses & Phone Numbers

📖 Summary

Graphic designer @ Audible, Inc. Produce and design the banner for corp. web site and affiliate site From November 2003 to May 2004 (7 months) Wayne, NJGraphic designer @ Samsung Electronics Produced and designed the print Ads for magazine, billboard, and newspaper. Major clients are Samsung Electronics, Microsoft, 3M, and Adidas. From July 2002 to November 2002 (5 months) Ridgefield, NJjr. art director @ brand24 From 1998 to 2001 (3 years) Sr. Global Label Specialist @ Edwards Lifesciences Working under highly regulated Federal Drug Administration (“FDA”) environment in the Labeling department.Identify and thoroughly analyze all inputs and outputs of a proposed solution to discover risks and propose mitigation strategies or configuration solutions for labeling process.Redline existing labeling documents or create new labeling.Organize and track each task and ensure labeling assistant to process next step. From August 2012 to January 2014 (1 year 6 months) Irvine, CAAssociate, Labeling @ Abbott Vascular Devices Ensures project team to determine artwork/labeling specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required.Creating labels for vascular products and managing documents according to FDA regulation in the company’s documentation database application.Providing upper level management with the labeling resources required to prepare for new product launches, including help in planning for FDA and CE approval.Communicating and meeting with vendors and customers to improve packaging material and planning new implementation of packaging materials, including Instructions for Use and labeling cartons.Revising procedures, including Standard Operating Procedures (“SOP”) & Detailed Operating Procedures (“DOP”) according to new regulations from FDA and our international notified body.Responsible for labeling CAPA. From May 2005 to August 2012 (7 years 4 months) Temecula, CASr. Graphic designer @ Coltene Whaledent Produced and design the print Ads for magazine, web, and newspaper. Assisted in coordinating and ensuring communication between departments to ensure a quality project was delivered. From December 2002 to September 2003 (10 months) Regulatory Affairs Labeling Manager @ Medtronic Irvine, CAManager, Document Control / Labeling @ Alphatec Spine • Develops key Quality Management System policies, procedure, work instructions, and metrics related to or affected by document control, change control, and labeling activities.• Manage the overall flow and assignment of document control tasks to department personnel, distributing work among personnel accordingly.• Ensures requests for priority and expedited changes orders are met.• Trains external departments on document and change control procedures, processes, and method.• Responsible for entire product labeling including creation, development, and approval of labeling documents.• Ensures proper revision control and label specification integrity.• Create new labeling process per company needs.• Lead the selection and implementation of Unique Device Identification (UDI) label per FDA’s requirement which meets the global requirements for all markets serves.• Create brand new labeling procedures including Company Policy, Standard Operating Procedures (“SOP”), and Work Instruction (WI).• Create and implement a brand new label template including barcode per UDI to update entire Class I, II, and III device.• Support creating Global UDI Database (GUDID) to submit FDA with Regulatory Affair as a team.• Lead the integration of label system elements into production systems.• Making an assessment to select the global label system to meet company’s future growth including manufacturing and distribution expansion.• Testing of labeling system software, as well as troubleshooting the software, and working to optimize the system for all users.• Revision of procedures and maintenance of work instructions, SOPs, templates, and associated documents relating to the labeling function according to new regulations from FDA and international notified body.• Create and execute Test Protocol (TP) to validate new labeling system.• Develop and maintain content and graphic standards as proposed by Corporate, Regulatory and Global guidelines. From January 2014 to September 2017 (3 years 9 months) Carlsbad, CA