16 years experience in the Bio-Pharmaceutical field working under cGMP specifications. Assisted in Technical Transfers of products. Worked in a multi-product facility. SOP revisions. Trained in Trackwise and Operational Excellence.
Prepare cleaning solutions for process needs. Clean, assemble and autoclave process equipment to cGMP specifications. Revise SOP's to reflect current practices. Qualified trainer on all areas of Equipment Preparations. Supervisor Delegate. Trained in Trackwise, Datastream and MFGPRO.
Prepared buffer and media solutions to cGMP specifications for process needs. Cleaned, autoclaved and depyrogenated process equipment. Assisted in Technical Transfer of products. Assisted in trouble shooting automation for multi-product facility. Revised SOP's to reflect current practices. Trained in Operational Excellence to help streamline the process. Was subject matter expert in SAP for my department.
Performed employment verifications on potential employees. Data entry. Created final draft of all employee reviews for CEO approval. Preformed new hire briefing to all employees.
Prepared buffer solutions for purification process. Cleaned, autoclaved and depyrogenated process equipment. Assisted purification in final fill of product. Trained on UF/DF skids.
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