*** Relocating to Washington State ***

  Quality control professional in the biotechnology field with more than 10 years of hands-on experience.

  Consistently promoted to positions of greater responsibility for exceeding performance objectives.

  Safety conscious professional with experience collaborating effectively with colleagues in the laboratory.

  Trained and educated colleagues on best practices of laboratory operations and tests.

  Familiar with Total Organic Carbon (TOC); Conductivity Raw Materials USP; European Pharmacopoeia (Ph. Eur) UV-Vis Spectrometer; Fourier Transform Infrared Spectroscopy (FTIR); High Performance Liquid Chromatography (HPLC); and Corrective and Prevention Action (CAPA) Change Control.

  Strong knowledge of Laboratory Information Management System (LIXXXXXX) and adhering to current Good Manufacturing Processes (cGMP), with knowledge of U.S. Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) and Occupational Safety and Health Administration (OSHA) standards.

  Proficient with Microsoft Office Suite.

Boehringer Ingelheim (formerly Amgen) Fremont, CA Nov. 2006-Present

Senior Associate (May 2014-Present)

Associate (Nov. 2006-May 2014)

  Communicate effectively with manufacturing and quality assurance personnel to ensure testing is completed promptly, accurately and efficiently.

  Ensure appropriate samples are retrieved for quality and compliance tests.

  Conduct analytical tests on raw materials, drug products and intermediates.

  Perform wet chemistry; HPLC; Total Organic Carbon; Conductivity; and other Compendial assays.

  Complete analytical, validation and investigative data review for compliance and identification issues.

  Contribute to method validation and method transfer activities, and draft detailed reports from laboratory investigations and for Standard Operating Procedures (SOPs).

  Gain the trust, confidence and respect of superiors to serve as a Technical Trainer.

Johnson & Johnson, Alza Corp. Menlo Park, CA Nov. 2005-Nov. 2006

Chemist I (Feb. 2006-Nov. 2006)

Lab Technician III (Nov. 2005-Feb. 2006)

  Conducted routine analytical testing to support raw material, lot clearance and stability study tests.

  Completed analyses using HPLC; Gas Chromatography (GC); UV Spectrometry; FTIR; Near Infrared (NIR), Atomic Absorption Spectrometry (AAS); and Karl Fischer techniques.

  Evaluated results against established specifications to release components and finished products.

  Performed Acceptable Quality Levels (AQLs) for finished products.

  Participated in special projects to validate lab equipment, analyze method transfers and for SOP reviews.

  Trained other chemists in everyday laboratory functions.

  Calibrated and maintained laboratory equipment to ensure continued functionality.

Bachelor of Science (BS), Biochemistry, San Francisco State University San Francisco, CA