LUZAYADIO BINGANA

**** ********* **, *********, ** 30189

Phone: 706-***-**** (Primary),

Email: ad24v7@r.postjobfree.com

QUALIFICATIONS

•Seasoned quality control and manufacturing professional of the pharmaceutical industry.

•Solid background in the application of cGMP, cGLP, USP monographs, DEA, and FDA guidelines.

•Extensive experience with HPLC, GC, AA, UV, XRPD, DSC, NMR, Raw Materials, Dissolution, USP Water micro-Testing, IPC sample, Assay, and Impurities.

•Experience with software packages such as Empower, ChemStation, Millennium, MS Word, and Excel.

•Strong time management skills, organizational skills, and effective research skills.

•Excellent problem solving, conflict resolution, interpersonal, and communication skills.

•Motivated self-starter and team player dedicated to quality, excellence, and safety in the workplace.

PROFESSIONAL EXPERIENCE

Chemence Inc, Alpharetta, GA September 2020 - October 2022 Quality Control Chemist

•Analyzing raw materials such as crude monomer, distilled monomer (CI3500F, CI3130, ECYA) using GC to determine the percent purity, known and unknown compounds,

•Test polymers viscosity, hardness and photo speed using instruments such as viscometer ( Brookfield LV, RVT, Cap 2000+), merigraph instrument, developer marigraph unit and exposure unit, Water content by Karl Fisher

Pharma Tech Industries, Royston, GA January 2019 – September 2020 Chemist II, Quality Control

•Perform daily routine analytical testing for raw materials and for stability using instruments such as, KARL Fisher, HPLC, UV Spectometer.

•Conduct daily chemical and physical testing on raw materials, intermediates, and final product API.

•Validate methods for submission to governmental organizations.

•Review validation documents submitted by other chemists in the department.

Cambrex Corporation, High Point, NC September 2017-November 2018 Chemist II, Quality Control

•Conduct routine analytical testing for raw materials and stability for research development using instruments such as XRPD, DSC, NMR, KARL Fisher, and HPLC.

•Peer reviewed stability documents and methods.

•Participated in interviews for company candidates in the Chemistry department.

Thermo Fisher Scientific, Greenville, SC July 2015-August 2017 Scientist II, Quality Control

•Conduct chemical and physical testing on raw materials, intermediates, and final product API.

•Utilize HPLC, GC, UV, pH meter, auto titrator, and other analytical instrumentation.

•Participate on preparing raw material study and pull samples for scheduled stability testing.

Cadista Pharmaceuticals, Salisbury, MD Jan. 2011-July 2015 Chemist II, Quality Control

•Conducted routine analytical testing for the release of raw materials, in-process, and finished products.

•Tested samples according to FDA, cGMP, and USP requirements and approved written procedures.

•Analyzed cleaning verification and process validation protocols in support of manufacturing campaigns. Analyst III, Quality Control

•Performed analyses on incoming in-process, raw material, finished product, and stability samples.

•Followed established methods for sample preparation using analytical and wet chemistry techniques.

•Participated in deviation investigations to determine the root cause of laboratory testing discrepancies.

Qualitest Pharmaceuticals, Inc. Charlotte, NC July 2007 - June 2009 Chemist, Quality Control

•Performed biochemical and chemical analyses of materials such as raw materials, inprocess materials, stability, finished products, and process validation samples.

•Reviewed and approved laboratory test data and documentation for completeness and compliance.

•Followed chain of custody procedures for handling and testing of DEA controlled substances.

•Adhered to strict SOP and cGMP documentation practices under USP and FDA guidelines.

Leiner Health Products, Fort Mill, SC Chemist, Quality Control April 2005 - June 2007

•Inspected and analyzed finished product, raw materials, in process, stability and validation samples to ensure compliance with specifications, procedures, policies and regulatory requirements.

•Provided technical expertise in support of laboratory investigations for OOS and OOT results.

Technician, Quality Control Aug. 1999 – April 2005

•Performed analysis on Heavy Metals, Arsenic, Particle Size, and Bulk Density for Raw Materials.

•Maintained, reviewed, and revised individual and team logbooks and laboratory notebooks.

•Performed assay on Beta Carotene, Acetaminophen, and Calcium.

•Participated in the release of Finished Products and Stability Samples.

•Prepared and maintained Test Solutions for Quality Control laboratory.

•Performed the following analytical testing procedures: Disintegration, Dissolution, Friability, Hardness, Titrations, Weight Variation, Average Tablet Weight, Particle Size Distribution, Bulk/Tapped Density.

EDUCATION AND ONGOING PROFESSIONAL DEVELOPMENT

•B.A. in Chemistry, The University of North Carolina, Charlotte, NC Dec. 2004

•Completed workshops in HPLC Troubleshooting, Analysis, root cause analysis and Writing reports for better Investigations.

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