Summary
Overview
Work History
Education
Skills
Affiliations
Accomplishments
Languages
Timeline
Generic

Obie W. Warren

Tampa

Summary


  • Scientist with comprehensive experience in quality control and chemical analysis. Skilled in laboratory techniques, instrument calibration, and compliance with industry standards. Strong focus on team collaboration and achieving reliable results. Adaptable and dependable in dynamic environments. Excellent problem-solving skills and attention to detail.
  • Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis.
  • Advanced level understanding of cGMP, OSHA, FDA, GLP, SOP, USP, and DEA policies within the laboratory.
  • Possess software applications skills, i.e. Microsoft Office, Excel, StarLIMS, LIMS/LABWORKS, TrackWise, Data acquisition systems such as Empower, Total Chrome and Chromeleon.
  • 12 years in tire and chemical manufacturing labs, physical and chemical testing (Instron, GC, TGA, Rheometrics, UV/Vis, AA, SEM, Pilot Plant operation) Excellent Mechanical Aptitude:
  • 3 years electronics technician experience (access control, satellite installation)
  • 1 year Plant Operations experience (Chemical Plant, Wastewater Treatment Plant) Personal Attributes:
  • Pays close attention to detail, adept at interpreting and evaluating results, and manages time effectively with quick turn-around of data, self-motivated.
  • Strong documentation, organization, and communication skills; ability to prioritize and multi-task while keeping a positive attitude

Overview

33
33
years of professional experience

Work History

QC Chemist

Lonza
03.2019 - Current
  • Analysis of dry product stability and finished product samples according to the assigned specifications, analytical methodology and protocols in a GMP laboratory setting with emphasis on attention to detail and accuracy of execution
  • Documentation of results in accordance with cGMP
  • Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner
  • Reports lab testing data and completes documentation accurately and in accordance with laboratory procedures and regulatory requirements
  • Reviews results for conformance to standards
  • Peer review work and data of other analysts to ensure compliance with method and regulatory requirements
  • Perform analytical testing of pharmaceutical products following analytical methodology
  • Read and interpret analytical methodology and the USP
  • Supports method development and the validation of new methods
  • Performs investigations and completes CAPA in response to deviations
  • Actively participates in customer and regulatory audits
  • Develops and executes validation protocols for test methods and equipment qualification as requested
  • Meet fundamental CGMP requirements relating to conduct and work practices to ensure the SISPQ (Safety, Identity, Strength, Purity, and Quality) of all the products manufactured/tested at Lonza Tampa
  • Performs other laboratory support activities as requested

Scientist, Quality Control Laboratory

Catalent Pharma Solutions
03.2017 - Current
  • Perform analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, water, manufacturing and environmental sampling and testing according to the established protocols methods and compendials
  • Prepares reagents, standards, medias, etc
  • Needed for analysis
  • Interprets and tabulates results of analyses, records results in approved notebooks, reports and logbooks
  • Log results in GLIMS database
  • Reviews and verifies co-workers calculations in notebooks/logbooks and verifies results to check for accuracy and integrity of data
  • Help develop new analytical methods and modify current methods
  • Assist in providing training to new or existing personnel
  • Participate in routine maintenance, basic repairs and calibration of laboratory equipment

Quality Control Chemist

PAR/Qualitest Pharmaceuticals
04.2007 - 10.2016
  • Conducted quantitative and qualitative analysis of pharmaceutical drug products following FDA, cGMP, GLP, USP, and the company’s Standard Operating Procedures in the Quality Control laboratory
  • Processed and reported HPLC and UPLC instrumental analysis using the Waters Millennium/ Empower data processing software and StarLIMS
  • Identified basic technical issues, atypical or out-of-specifications test results, out-of-trend test results, instrument malfunctions, and methodology problems; and participates in the investigation to resolve and correct with the use of Trackwise software
  • Responsible for preparation and documentation of test solutions, reference standard solutions, standardization of reagents, buffers, and mobile phases
  • Analyzed finished product and stability samples using appropriate instrumentation, such as dissolution apparatus, disintegration apparatus, UV/Visible and Infrared spectrophotometers, FTIR, Karl Fischer, TLC, pH potentiometer, moisture analysis, hardness tester, HPLC, and UPLC
  • Revised and updated standard operating procedures as needed
  • Calibrated and maintained laboratory instruments and equipment

Associate Environmental Chemist

Enersolv Corporation
01.2011 - 08.2016
  • Implemented current methodology in the analysis of drinking water, wastewater, storm water, ground water, and industrial process samples in accordance with local, state, and federal guidelines in an ISO17025 accredited laboratory
  • Daily use of the Chromeleon software for ion chromatography (IC) digital data collection, and use of the Dionex-ICS-1600 system and Shimadzu TOC Analyzer
  • Use of LABWORKS LIMS for configuring the samples and NO2, NO3, IC, TC, and TOC results entry
  • Performed Whole Effluent Toxicity Testing using Ceriodaphnia dubia and Pimephales promelas to evaluate the potential harmful effects of effluents discharged into surface waters
  • Monitored abiotic testing conditions, such as temperature, pH, and dissolved oxygen

Senior Lab Associate

Operon Biotechnologies
01.2006 - 04.2007
  • Used DNA Synthesizer Towers in oligonucleotide chemical synthesis processes
  • Directed the operation, maintenance, and processing of data on Tower and High-Throughput Synthesizers
  • Provided training of new Synthesis Lab associates
  • Prepared standards, reagents, solutions

Electronics/Access Control Technician

Computer Sciences Corporation
01.2002 - 01.2004
  • Marshall Space Flight Center

Chemical Analysis Technician

Dunlop Tire Corp.
01.1992 - 01.1999

Education

B.S. - Chemistry

University of North Alabama
Florence, AL

M.S. program - Food Technology

Alabama A&M University
Normal, AL

Skills

  • Hazardous waste management
  • Instrument Calibration
  • Laboratory management
  • Good manufacturing practices
  • Sampling
  • Data log maintenance
  • Data interpretation
  • Sample preparation
  • Documentation review
  • Analytical chemistry
  • Chemical analysis
  • Spectroscopy techniques
  • Environmental monitoring
  • Laboratory processes
  • Lab equipment maintenance
  • Standard operating procedures
  • Safety protocols
  • Experienced in Empower 2 and Empower 3 software

Affiliations

  • Alpha Phi Alpha Fraternity, Inc., member
  • Food Science Club, President
  • American Chemical Society, member
  • Institute of Food Technologists, member

Accomplishments

  • Achieved greater efficiency in lab through effectively helping with Method Template creation
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Collaborated with team of 6 in the development of Yellow Belt project to improve lab reference standard orgainization

Languages

English
Full Professional

Timeline

QC Chemist

Lonza
03.2019 - Current

Scientist, Quality Control Laboratory

Catalent Pharma Solutions
03.2017 - Current

Associate Environmental Chemist

Enersolv Corporation
01.2011 - 08.2016

Quality Control Chemist

PAR/Qualitest Pharmaceuticals
04.2007 - 10.2016

Senior Lab Associate

Operon Biotechnologies
01.2006 - 04.2007

Electronics/Access Control Technician

Computer Sciences Corporation
01.2002 - 01.2004

Chemical Analysis Technician

Dunlop Tire Corp.
01.1992 - 01.1999

M.S. program - Food Technology

Alabama A&M University

B.S. - Chemistry

University of North Alabama

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Obie W. Warren