Quality Control Analyst
Resume:
TIMOTHY A. HUNT, JR.
PROFESSIONAL PROFILE
Experienced Chemist skilled in GFAAS, FTIR, HPLC, GC & UV-Vis instrumentation with a proven record of building companies’ winning portfolios with a history of being a team player and great collaborator.
EDUCATION
Bachelor of Arts in Chemistry, Earlham College, Richmond, IN May 2001
PROFESSIONAL EXPERIENCE
Nitto Denko Avecia, Milford, MA September 2022 - present
Sr. QC Analyst – Raw Materials
Tested raw materials and in process samples by various techniques such as: GC, HPLC, UPLC, LC/MS, UV/Vis, FTIR, Moisture Analysis
cGMP & GLP compliant
Uses Chemstation and Empower to process GC, HPLC, UPLC and LC/MS runs
Takeda, Lexington, MA June 2018 – July 2022
QC Analyst II -Raw Materials
Tested raw materials and in process samples by various techniques such as: HPLC, GC, UV/Vis, FTIR, Osmometer, pH, titrations and various wet chemistry techniques
Performed raw material testing done in accordance to USP, JP & EP compendia and company SOPs
cGMP &GLP compliant
Uses Trackwise system for deviations/OOS reports
LIMS proficient
Reviews and authorizes analyses in LIMS
On the Job Trainer for new employees in various assays.
Performs validation testing on new methods
Bristol Myers Squibb, Devens, MA February 2018 – June 2018
QC Analyst IV-Chemistry (Contract)
Performs routine stat testing on in process samples by HPLC analysis
Performs water testing (TOC, conductivity, pH testing)
cGMP &GLP compliant
Uses Trackwise system for deviations/OOS reports
LIMS & Smartlab proficient
Reviews and authorizes analyses in LIMS
Alkermes, Wilmington, OH June 2016 – June 2017
QC Analyst IV-Chemistry (Contract)
Tested raw materials and in process samples by various techniques such as: HPLC, GC, UV/Vis, FTIR, Viscometer, Osmometer, pH and various wet chemistry techniques
Performed raw material testing done in accordance to USP compendia and company SOPs
cGMP compliant
Wrote OOS reports/deviations with Trackwise system
Wrote, revised and reviewed SOPs
Participated in training of less experienced staff
Reviewed QC Data for compliance to procedures and specifications
Genzyme, Allston, MA March 2015 – December 2015
QC Analyst III-Chemistry (Contract)
Tested intermediate and final product samples by various techniques such as: HPLC, GC, Gel Electrophoresis, UV/Vis and multiple types of spectrophotometry
Performed raw material testing done in accordance to USP compendia and company SOPs
cGMP compliant
Wrote OOS reports/deviations with Trackwise system
Maintained equipment calibration annually/bi-annually
Participated in training of less experienced staff
Reviewed QC Data for compliance to procedures and specifications
Lantheus Medical Imaging, North Billerica, MA January 2014 – January 2015
QC Chemist III (Contract)
Tested and released finished products by way of analytical chemistry techniques
Performed a wide variety of analyses on instruments such as: GC, HPLC, UV-Vis spectrophotometer, TOC-900, auto-titrators, pH, FTIR, & AA for product releases
Trained in LIMS for data entry purposes
Maintained preventative maintenance and bi-yearly and yearly calibration on various instruments
Performed other laboratory tasks working closely with other departments that support Quality Control
Wrote technical documents, reports, protocols, SOPs, etc.
cGMP and 21 CFR compliant
Used USP and EU compendia for various testing
Sonar Products, Carlstadt, NJ May 2013 – January 2014
QC Chemist
Performed quality control analyses on in-process, homogeneity on first batch samples, finished products and stability samples in accordance with established specifications and procedures
Tested and released raw materials for production use
Used Microsoft Excel to validate accuracy of data from HPLC assays
Maintained calibrations of various instruments
Trained new hires on FTIR, wet chemistry and HPLC assays
Trained experienced chemists on Waters technology for Alliance HPLC
Vi-Jon, Smyrna, TN October 2012 – May 2013
QC Chemist (Contract)
Independently performed a wide variety of analyses on instruments such as: GC, HPLC, RV and LV Viscometers, auto titrators, pH, FTIR and specific gravity densitometer to qualify product releases
Completed Quality Control testing on in-process and finished products as well as on stability samples in accordance with established specifications and procedures
Executed maintenance, system suitability and calibrations on instrumentation weekly, monthly and yearly
Carried out wet chemistry testing and releases raw materials for production use
cGMP and 21 CFR compliant
Trained in USP, FCC and ACS testing methods
Experienced SAP user, a program that records data of testing and releases approved product to production
MassBiologics Laboratories, UMASS Medical School, Boston, MA October 2005 – April 2011
QC Material Control Analyst II
Managed Quality Control testing and analyzed test results in order to meet production deadlines; ensured that all tests carried out according to established specifications and procedures
Coached junior and senior lab technicians on lab duties required to meet Quality Control department objectives
Executed with excellence troubleshooting of all Quality Control instrumentation and ensured all equipment calibrated and functional
Worked extensively with GFAAS, FTIR, UV-Vis, (A280, Bradford nitrogen & aluminum testing), Sievers 900 TOC Analyzer, BCA VERSAmax plate reader, HPLC and specific gravity densitometer
Wrote reviews and revised SOPs, wrote deviations reports and change controls
Developed and evaluated new testing procedures, performed assay validations and carried out special analyses when needed
Identified and solved technical and scientific problems that arose
Performed wet chemistry testing and releases raw materials for production use
Supervised Quality Control Analyst 1, technicians and/or lab assistants
Worked with toxic and infectious materials
cGMP and 21 CFR compliant
Assisted in site audits of outside testing facilities
Trained in LIMS, Master Control, and aseptic gowning techniques
L'Oreal USA, Florence, KY January 2005 – October 2005
Industrial Quality Chemist
Provided analytical support of process and product development projects and performance of routine GMP compliance related activities Instructed compounders on what raw materials went into a batch and reviewed work orders in case adjustments were necessary
Worked extensively with the HPLC, GC, FTIR, and UV-Vis spectrometer testing preservatives and actives for the various in-process, raw materials and finished goods
Performed safety audits weekly in anticipation of achieving VPP status in the state of Kentucky
Attended monthly safety meetings
Assisted in SOP revisions and practiced GMP standards
Andrew Jergens Company/Kao Brands, Cincinnati, OH April 2004 – December 2004
Quality Control Analyst (Contract)
Assisted in revising SOPs and implementing GMP
Gained valuable knowledge in microbiology testing techniques in everyday environmental sampling
Worked extensively with the HPLC, GC, NIR, FTIR, and UV-Vis spectrometer
Knowledgeable in the testing of raw materials, in-process, and finished products
Prepared solutions, standards, and reagents
Gentest/Becton & Dickinson, Woburn, MA November 2002 – March 2003
Lab Technician (Contract)
Performed tasks such as making up various sterile solutions for cell cultures and oocytes, sterilizing the solutions and flasks via autoclave and cleaning glassware
Metrisa Inc., Bedford, MA May 2002 – October 2002
Manufacturing Chemist/Quality Control Chemist (Contract)
Performed analytical testing in a QC setting on finished assembled instruments called Sentinels and FPA’s
Prepared solutions, standards, and reagents
Became fluent in the operation, calibration, and repairing of these various titrators
Cargill Corn Milling Plant, Dayton, OH August 2001 – April 2002
Quality Assurance Chemist (Contract)
Performed analytical testing in a QC setting on in-process, finished product and raw materials
Operated, calibrated, and repaired lab instruments
Participated in monthly CRA/Silliker crosschecks and knowledgeable in MSDS
Contact this candidate