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Quality Control Chemist

Location:
Bethlehem, PA
Posted:
April 24, 2014

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Resume:

Gilbert Velazquez

**** ********** **.

Bethlehem P.A. 18018

E-mail acduod@r.postjobfree.com

Phone 610-***-****

Objective To obtain a challenging position as an Associate Scientist/Chemist in a fast paced environment with opportunity to grow.

Experience

Biotechnician 1

Merck Pharmaceuticals

West Point PA

Apr 2013-Jul 2013

Responsible for various aspects of vaccine manufacturing while following Standard

Operating Procedures. Worked primarily in the “cell side” manufacturing area. All

work was performed in a Class 100 sterile environment. While following a batch

record and using good aseptic technique, proceeded to clean, assemble, operate,

disassemble and troubleshoot equipment in order to meet production schedules.

Was involved in the manufacturing of a number of several buffers and growth

media which required the use of different pumps, filtering equipment, transfer

equipment, vessels and proper labeling. Additionally documented all work

according to proper cGMP and performed review of manufacturing documentation.

QC Chemist

Johnson Matthey (Joule Scientific)

Conshohocken PA

Jan 2013-Mar 2013

Primary duties are to test incoming in-process samples of Active Pharmaceutical

Ingredients (API’s) in order to provide the production group with accurate results in

a timely manner. Additionally tested raw materials, finished products and stability

samples. Most of the samples tested were Class II controlled substances. Among

tests performed are Assay, Impurities and cleaning verifications by HPLC (Agilent

1100 and 1200 series using Empower software), and GC (Agilent 6890 and 6850

series). Other tests include but are not limited to Karl Fischer, LOD, UV/VIS, FT-IR,

ROI, automated titrations, and numerous wet chemical analyses. All tests were

performed under current USP guidelines. Conducted OOS and OOT investigations

and documentation. Maintained all notebooks, assay reports, calibrations,

standards, log books and other documentation in accordance with CGMP.

QC Chemist Hovione

Scientific Search)

East Windsor NJ

Aug 2011-Aug 2012

Primary duties are to transfer recently validated HPLC and GC methods from the

RD department, and from outside customers into the Quality control department to

be used for in-process and final dose testing. The tests most frequently performed

include Assays, Impurities and cleaning verifications by HPLC (Waters 2690 and

2695 series using Empower3 software), and GC (Agilent 6890 series with direct

injection as well as headspace). Other tests performed include but are not limited

to Karl Fischer, PSD, LOD, UV/VIS, FT-IR, ROI, automated titrations, and

numerous wet chemical analyses. Assisted in the review of laboratory notebooks,

troubleshoot analytical laboratory equipment and performed statistical analysis of

laboratory data as needed. Also participated in the maintenance, qualification and

validation of various instruments. Maintained all notebooks, assay reports,

calibrations, standards and other documentation in accordance with CGMP.

QC Chemist

HH&P (Scientific Search)

Lawrenceville NJ

May 2010-Jan 2011

Primary duties are to test incoming finished products, in-process samples and

stability samples for the liquid manufacturing group. Among the samples tested

were suspensions, liquids and solid dose samples. Among tests performed are

Assay, Impurities and cleaning verifications by HPLC (Waters 2690 and 2695

series using Empower software), and GC (Agilent 6890 series). Other tests

performed include but are not limited to Karl Fischer, TOC, PSD, LOD, UV/VIS, FT-

IR, ROI, automated titrations, and numerous wet chemical analyses. Performed

daily testing and monitoring of the water supply. Assisted analytical method

development in method validation studies when needed, review of laboratory

notebooks, conduct investigations for out of trend results, troubleshoot analytical

laboratory equipment and performed statistical analysis of laboratory data as

needed. Also participated in the qualification and validation of various instruments.

Maintained all notebooks, assay reports, calibrations, standards, log books and

other documentation in accordance with CGMP.

QC Shift Chemist

Lonza Inc. (Aerotek Scientific)

Conshohocken PA

Aug 2008-Dec 2009

Primary duties are to test incoming in-process samples of Active Pharmaceutical

Ingredients (API’s) in order to provide the production group with accurate results in

a timely manner. Assist analytical method development in method validation

studies when needed, peer review of laboratory notebooks, conduct investigations

for out of trend results, troubleshoot analytical laboratory equipment and performed

statistical analysis of laboratory data when needed. Among tests performed are

Assay, Impurities and cleaning verifications by HPLC (Agilent 1100 and 1200

series using Empower software), and GC (Agilent 6890 and 6850 series). Other

tests include but are not limited to Karl Fischer, LOD, UV/VIS, FT-IR, ROI,

automated titrations, and numerous wet chemical analyses. Also was involved in

the qualification and validation of various instruments. All tests were performed

under current USP, BP and EP guidelines. Maintained all notebooks, assay

reports, calibrations, standards, log books and other documentation in accordance

with CGMP.

Associate Scientist

Teva Pharmaceuticals (Judge Scientific)

Sellersville PA

Feb 2008-Aug 2008

As part of the analytical services group, was involved in the tech transfer of

numerous procedural methods. These methods involved both raw materials and

finished products, including controlled substances. These methods were

transferred from other sites, research labs, responses to FDA letters of deficiency,

etc. They were performed under current USP, BP and EP guidelines. Was also

involved in the qualification of primary standards. Among tests performed: HPLC

(Waters 2690 and 2695 series) with Empower software (Assays, Related

Substances, etc), Gas chromatography (both liquid and headspace), Dissolution

testing, FT-IR, Karl Fischer, UV/VIS, Loss on Drying, Residue on Ignition,

Identification tests, pH, etc. Wrote final reports for each technical transfer, and for

primary standard qualifications. Maintained all notebooks, assay reports,

calibrations, standards, log books and other documentation in accordance with

CGMP.

QC Chemist

Accupac (Aerotek Scientific)

Mainland PA

Oct 2007-Dec 2007

Tested raw materials, in process samples, bulk products and finish products in a

pharmaceutical/personal care production facility. Performed aseptic sampling of

environmental samples for chemical and biological testing. These tests were

performed under current USP, BP and EP guidelines with approved methods.

Among the tests performed: FT-IR, Karl Fischer, numerous wet titrations, UV,

density, viscosity, fluoride content, loss on drying, loss on ignition, identification

tests, pH and conductivity. Maintained all notebooks, assay reports, calibrations,

standards, log books and other documentation in accordance with CGMP.

Research Technician

ExxonMobil (Manpower)

Annandale NJ

Nov 2006-Aug 2007

Participated in the testing of both raw materials and finish products of catalysis.

Performed a number of extrusions, calcinations, ion exchanges, impregnations

with precious metals, spray drying and steamings of zeolites. Worked with

pressurized reactors and hydraulic equipment. Performed numerous analytical

procedures: LOI, density, particle counts, crush, and ph. Maintained accurate

records of analysis, chemical inventory, labeling and storage of samples.

Lab Technician

Praxair-PDI (Manpower)

Bethlehem PA

Feb 2006-September 2006

Worked primarily in the EPA protocol lab with a number of gas process analyzers

and GC’s in order to determine gas concentration down to 10ppm level on high

pressure cylinders. Maintained accurate records of analysis, and performed data

entry and calculations on Excel spreadsheets. Performed calibration curves on a

routine basis. Responsible for instrument maintenance, accurate record keeping

and proper certification of standards.

Education B.S Biology with Chemistry minor

Kutztown University

Kutztown PA.

Sept 1992-Dec 1996

Software

Proficient with the use of the following software: Empower, Millenium, Excel,

Word, Powerpoint, Access, Lotus notes, LIMS, Documentum and various other

spreadsheets and word processing programs.

Languages

Fluent in both Spanish and English



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