Analytical Chemist, Wet Chemistry, Instrumentation

Experience

Chemist I December ****-June ****

Nitto Avecia Pharmaceutical Services (formerly Irvine Pharmaceutical Services)

Analytical Chemistry – Raw Materials Analysis

Conducted compendia testing including but not limited to the following: FDA, USP, EP, JP, BP, IP, ACS, FCC, ICH, client method, stability methods, in-house methods, method feasibility, method development, method verification

Documented and performed work and observations according to cGMP and GDP

Mentored Chemists in Analytical Chemistry Lab

Peer reviewed colleague’s work and ensured reagent preparations were within compliance

Handled, tested, documented, and disposed of Controlled Substances

Created Document Change Requests in Master Control including but not limited to: worksheet revisions and method verifications

Investigated deviations, nonconformances, unexpected results, and out of specifications

Operated Instruments including but not limited to the following: FT-IR Spectroscopy; Fluorescence; Force Testing Penetrability; UV-Vis Spectroscopy; Total Organic Carbon; Conductivity/pH; Karl Fisher Water Content (Coulometric and Volumetric); Mercury Analyzer – Atomic Absorbance Cold Vapor; Turbidity

Performed wet chemistry testing including but not limited to the following: Glass Containers, Rubber Stoppers, Heavy Metals, Identification, Specific Gravity, limits, assays, and particle size distribution

Verified balance and pipette calibrations

Maintained basic laboratory housekeeping and reagent inventory

Consolidated chemical waste based on state and federal regulations, manufacturer’s Safety Data Sheets, and internal laboratory protocol

Worked with team to meet deadlines to accommodate standard turnaround times and rush jobs

Technologist April 2015-October 2015

NAMSA

Analytical Services

Performed analytical testing in accordance to FDA, CFR, ISO, and USP testing under cGMP guidelines and compliance with SOP and test methods.

Trained technologists in usage of analytical instrumentation

Managed wet chemistry laboratory testing

Investigated nonconformances, unexpected results, and questionable lab results and determined root cause. Documented findings in TrackWise System.

Analyzed and identified unknown and known materials for client investigations by FT-IR spectroscopy (microscopic, attenuated total reflectance, and open beam)

Hands-on experience with GC (ChemStation and TotalChrom)

Tested incoming raw materials and final material according to client test specification for developmental research and GMP lot release.

Chemist Internship June 2014- April 2015

Glaukos

Prepared and analyzed High Performance Liquid Chromatography samples for developing combination devices. Designed method for elution study on the HPLC.

Communicated data in applied research department and analyzed further development in projects and process improvement.

Followed Standard Operating Procedures and current Good Manufacturing Practice in preparing chemical solutions.

Created and tested solutions on needles to improve designs in ongoing glaucoma treatment research.

Education

Bachelors of Science, Chemistry September 2014

Specialization: Biochemistry

University of California, Irvine

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