Experience

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  Melaleuca Inc

  • Stability Chemist

    • Oct 2007 - Present

    Products: OTC Dermatological, Dental, CosmeticsSupervision: Supervise three Laboratory TechniciansStability Responsibilities include: Coordinate and perform all activities related to the Stability, Annual Product Review and Product Retention Evaluation programs in compliance with Company SOPs and cGMP Regulations. Protocol development, project implementation, sample management, and implementation of FDA/ICH regulations. Prepare stability sampling and testing schedules to include all products to be placed into the annual controlled room temperature system, and the pulling of periodic test interval samples within the program. Distribute samples at required intervals to areas performing evaluations. Maintain data tracking systems and perform trend analysis of Stability test results. Initiate alert reports to associated areas when trends are indicative of shelf life excursions, or test results are atypical. Assist in maintaining the stability chambers for chambers for adherence to established environmental requirements and auditing of stability logbooks. Prepare a formal summary report of data reviewed in each section of the Annual Product Review (APR). Analytical Chemist Responsibilities include: performing analytical chemistry assays based on new and existing methodologies, operating analytical instrumentation such as HPLC(Hitachi-EZChrom Elite), GC(Agilent 6890N-Chemstation), ICP(Thermo), TOC(GE Sievers), Karl Fischer Titration (Mettler Toledo), optimization and validating analytical testing methodology used to control raw materials, production intermediates, and final products, writing technical reports to document analytical. Also, coordinated off-site testing as necessary and conducted testing of analytical samples for the Quality Department.

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  Lancaster Laboratories

  • QAL-Chemist

    • May 2005 - Oct 2007

    Products: BiopharmaceuticalResponsibilities include: Analytical analysis of biopharmaceutical protein content and environmental quality analysis of in-process water (USP WFI, WPU, Steam Clean, and Caustic Rinse) using UV-Vis, pH, Conductivity, LAL Endotoxin testing (gel clot and turbidity), and TOC (Tekmar) instrumentation. Calibration, Maintain, Standardize, and laboratory equipment. Operational and documentation compliance with cGMPs/CRFs, SOP, GLPs, and Safety guidelines established by Amgen Inc. Lims database sample reception, data entry and approval. Responsible for reviewing results of other analytical staff, communicate and coordinate sample results and schedule with Manufacturing and Purification supervisors. Initiate and participate in laboratory deviation/investigation reports

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  Stiefel Research Institute

  • QC Analyst

    • Jan 2000 - May 2002

    Products: Pharmaceutical-DermatologicalResponsibilities include: Analysis of raw materials, finished products, stability, and compendia testing as specified by the USP, EP, JP, BP, ACS, and the Food and Chemical Index. Analysis with FTIR, TLC, pH/Conductivity, UV-Vis, capillary viscosity, auto titration, Karl Fisher water titration, TOC, Fluorometer, Polarimeter, distillation, and wet chemistry techniques. Document and analyze assay results in compliance with GMP and SOP guidelines, enter and approve results in Lims database.