Quality Control Manager/Analytical Chemist

As an established Quality Control Manager, I have extensive experience in quality assurance, instrument qualification, procedure writing, analytical methods development, transfer and validation. I Possess expertise with FDA, ICH and EU requirements for pharmaceutical, drug substance, drug product and device testing. I Collaborate effectively with outside vendors and internal groups including assay development, manufacturing, quality assurance and product development. I am proficient in troubleshooting and repairing analytical instrumentation. • Materials Management • Vendor Qualification and Auditing • cGMP Compliance • Data Trending • Methods Development and Transfer • Protocol and Report Writing • Hazardous Materials Management • CAPA Determination and Implementation I am seeking an opportunity to utilize my abilities as an analyst and as a mentor for less experienced analysts, in order to improve the Quality Control aspects of a pharmaceutical, biotechnology or device manufacturer. With my previous experience, I can provide support in a company's effort to prepare for a FDA inspection.

Chemist

Chula Vista, CA