Quality Control Chemist
Resume:
Gilbert Velazquez
Bethlehem P.A. 18018
E-mail *********@*****.***
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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