Brian Dameron Email & Phone Number

Arlington Heights, Il, Us

Experience:-Team member for radiopharmaceutical Product Labeling, Package Inserts (PI), and Instructions for Use (IFU).-Initial Digital Batch Records (DBR) project team member.-SAP Site Authorization Owner (SAO) for GEHC USA, Canada, Puerto Rico and Chile.-SAP SME for Quality Control, Manufacturing, Warehouse related activities in SAP ECC6.Quality Control / QC Raw Material responsibilities-Managing Raw Material Sampling for internal and external raw materials-Managing the Non-Routine Raw Material (NRQC) process-Managing the Retain Sampling process -Drug product batch review and release -Change Management-Authoring and approving raw material and product investigations-Authoring and reviewing test specifications-Authoring and reviewing Standard Operating Procedures-Quality Control Raw Material testing, review and release-Quality Control in-process and Final Product testing and release-Designated Quality Control Trainer

Experience:-Project team member for the global implementation ERP SAP ECC 6 (System Application and Products).-Project team member for the implementation of the Unique Device Identification (UDI) for Radiopharmaceutical Devices.- Project team member for updating and maintaining radiopharmaceutical Product Labeling, Package Inserts (PI), and Instructions for Use (IFU)-Project team member for manufacturing site transfer of two radiopharmaceutical products-Project team member for packaging change to nuclear device-Project team member for the implementation of new nuclear device productsQuality Control responsibilities-Change Management-Authoring and approving material and product investigations-Authoring & Developing test specifications-Authoring Standard Operating Procedures- Authoring Validation Protocols, User Requirement Specifications and Validation Test Scripts-Product batch record review and product release-Quality Control Raw Material testing, review and release-Quality Control In-process and Final Product testing and release-Designated Quality Control Trainer

- Change Management- Authoring investigations- Authoring Standard Operating Procedures- Created and managed the tracking of all changes (Document & Facilities) for three sites - Created and managed Microsoft Access database to track and control paper documents and document book sets which were located throughout four facilities, one located in the UK- Managed all documentation updates ( update to paper documents, routing of paper documents for review(s) and approval(s), implementation of paper document and replacement and receipt (including accountability of obsoleted documents) for four sites.- Designated Trainer- Project participation: - Site wide document transfer from paper to an Electronic Document Management System, Documentum. - Performed validation and user acceptance testing on new Electronic Document Management System, Documentum - Implementation of new nuclear device products