THERMO FISHER SCIENTIFIC – $129,584.00/Year

Required knowledge or experience withbr br Providing training to Quality Control and other staff;br Internal and customer audits;br Quality standard e.g., ISO 13485, FDA, ICH International Council for Harmonization Quality guidelines;br Tropix and POROS analytical testing;br HPLCs, UV, FTIR and other relevant analytical equipment;br ISO 13485 requirements including CAPA, Risk Assessments, Deviation investigation and Change Control process;br Document review including inprocess, final batch release and stability data;br Set up and maintenance of product stability programs and sampleraw material retain programs;br SAP, Trackwise, Agile; andbr Continual process improvement practices such as Kaizens, Gemba, 5S, Standard Work and others.br br Will accept any suitable combination of education, training or experience.br br Travel Up to 25 travel required domestic only.