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Quality Control Analyst

Location:
Fall River, MA
Posted:
March 28, 2023

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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



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