Description
Experienced with trouble shooting issues in chromatography and other testing procedures resulting in effective and high quality test methods * Maintained daily, weekly, and quarterly checks of instrumentation such as stability chambers and HPLC systems as part of team responsibilities, reducing the need for a separate metrology group Scientist II (Laboratory Technical Services) 2011 Performed remediation activities for existing test methods. Responsibilities included writing protocols based on gap analyses, executing protocols, and writing validation reports based on results. All work performed in a quality control environment. * Completed projects to meet departmental timeline goals * Method validation activities performed in a GMP/GLP environment * Enhanced test methods and/or brought test methods up-to-date to current ICH and SOP guidelines Adamson Analytical Laboratory, Corona, CA 2001 - 2006 Senior Analytical Chemist (Quality Compliance) Performed routine analyses testing of neutraceuticals, vitamins, and cosmetics in a Quality Control environment. * Validated new testing methods according to latest FDA guidelines with an emphasis on HPLC methods. * Performed HPLC testing of cosmetics, raw materials, and OTC products according to SOPs, laboratory testing protocols, and US Pharmacopoeia. * Interpreted and revised data from scientific journals and foreign compendia for method development purposes. * Calibrated instrumentation as needed, and wrote SOPs for instrumentation use. * Reviewed peer chemists' laboratory notebooks for accuracy and completeness. * Assisted in training junior chemists on proper laboratory techniques and safety procedures.
Accomplishments
Highlights:
Keywords
- Filing
- Forth Programming Language
- Quality Assurance
- Regulatory Affairs
- Test
- High Performance Liquid Chromatography (HPLC)
- Instrumentation
- Quality
- Quality Control
- Compliance
- pharmaceutical
- sop
- change control
- method validation
- cleaning validation
- hplc
- fda
- raw material
- in-process testing
- finished product
- solid dose
- research and development
- method transfer
- protocol
- report
