Quality Control Testing
Resume:
Jennifer Lloren Mendoza
Fairfield, Ca. 94534
707-***-**** Home
707-***-**** Cell #
e-Mail: ******************@*******.***
Objective: To obtain an open position for Quality Control Microbiologist or
equivalent.
Education: A bachelor’s degree in Biological Science awarded from California
State University, Sacramento.
Work History:
Genentech, Inc.
1000 New Horizons Way
Vacaville, CA 95688
October 2009- present (Bioprocess Protein Purification Technician)
Participate in the routine production of mammalian cell culture products by
process of protein purification. Responsible for the operation and cleaning of
fixed tank systems used in manufacturing by the process of clean-in-place (CIP)
and steam-in-place (SIP), the operation and cleaning of the filtration systems,
and the operation of column chromatography systems. Other duties include:
buffer & reagent preparation, pH testing, conductivity testing, filter integrity
testing (bubble point and diffusion), aseptic sampling, column chromatography
review, troubleshooting, reports deviations using Trackwise software; monitoring
of process throughout operations and performs monthly 5S audit and FIT action
items for production area.
March 2009 – September 2009 (QC Equipment Validation Associate)
Performed temperature mapping of QC controlled environments using the
Validator 2000 hardware; wrote and executed validation protocols including IQ,
OQ and PQ for equipment; decommissioned retired equipment; ordered new
equipment for QC laboratories; troubleshooted equipment malfunctions as
necessary; wrote investigations for Procedure Deviations encountered during
equipment validation using Trackwise software; contacted vendors regarding
equipment information.
Dey L.P.
2751 Napa Valley Corporate Dr.
Napa, Ca. 94558
November 2006 – February 2009 (Microbiologist II)
Involved with bringing the annual requalification/validation of the rigid wall
isolators in-house; wrote and executed validation protocols for new testing such
as resin bioburden testing and Nasal drain monitoring and established
alert/action level for them; participated in continuous improvement group
sessions with black-belt trainer (ex: Lean Six Sigma); wrote and executed
validation protocols for laboratory improvement issues such as extending shelf
life of media made in-house; trained manufacturing, chemistry and Product
Development personnel on basic microbiology techniques and monitoring;
reviewed data for release of final product to packaging, facility water systems to
production and media release for use in the laboratory; performed Antimicrobial
Effectiveness Testing and Microbial Limits Testing on final product; performed
Bactericidal & Fungicidal testing; performed special testing for investigational
purposes such as pilot plant operations; met with vendors to choose new
equipment for the laboratory; coordinated annual gowning qualification for entire
cleanroom personnel company wide; conducted safety and housekeeping audits
for laboratory; tracked biohazard waste disposal for laboratory; held a leadership
role in the microbiology department.
September 2002 – October 2006 (Microbiologist I)
Wrote and executed protocols such as validating new equipment, new media and
new product for the company; wrote investigations for Corrective Actions,
Procedure Deviations and Lot Investigations using trackwise software; performed
SIP validation projects for FFS machines and sterilizers; wrote and revised
standard operating procedures and laboratory techniques; reviewed various
microbiological data such as routine monitoring and final product release;
performed Microbiology release into BPCS for sterility and final release of
product; coordinated specials testing and validation protocols; coordinated
Critical Work Order testing and gave final release of system to maintenance;
reported weekly excursion reports for upper management; coordinated media fill
validations; generated reports for monthly/yearly environmental trend report and
Key Performance Indicators for microbiology department; member of the
microbiology continuous improvement team and Quality System’s Environmental
Health and Safety committee; met with contract laboratories for outside testing
such as Microbial Ingress Testing; trained on using advanced equipment in
laboratory such as Rigid wall isolator and Biolog identification system; attended
seminars on work related topics such as Root Cause Analysis and Aseptic
Processing of Sterile Drug Products; involved with implementation of EMSS for
laboratory data tracking; performed safety training and procedure revision
training for department.
November 2000 – September 2002 (Microbiology Associate)
Performed gram staining, streaking for isolation, biochemical testing; used
automated identification system (Vitek and Biolog) for microbial identification;
read total aerobic count for various types of samples; reviewed the filling batch
record for microbiology department; performed quality control of media and
organisms; trained of new personnel; ordered supplies for laboratory; reviewed
manufacturing data such as magnehelic reading for cleanrooms and filter
datasheets.
October 1998 – November 2000 (Microbiology Assistant)
Performed sterility testing in cleanroom and by using a VHP isolator system;
perfomed endotoxin testing (LAL) and serial dilutions; plated various types of
samples for total aerobic count such as bioburden, water, utilities and end-of-lot
swabs by membrane filtration, pour plate and streak method; performed growth
promotion on various media and organisms; prepared media and reagents.
January 1998 – October 1998 (Microbiology Laboratory Technician)
Performed environmental monitoring of FFS machines (class 100) and clean
rooms (class 100,000) such as viable and non-viable air shower monitoring
during filling using SMAs and Climet; performed nozzle surface swabbing during
end-of-lot; perfomed viable air microbial monitoring using RCS and SAS;
performed surface monitoring using contact plates and swabs; collected utilities
such as nitrogen, clean steam and compressed air for testing; collected water
from system such as City water, DI and PW for testing; tested HEPA & room air
using velocity probe and Climet; performed personnel monitoring; collected
validation swabbing samples of machine and tanks for chemistry and
microbiology; performed media fill inspection; followed cGMP practices; used
aseptic technique; autoclaved test supplies; qualified for gowning in cleanroom
environment.
Monsanto Chemical Plant
1778 Monsanto Way
Martinez, Ca. 94553
September 1997 – September 1999 (Chemistry Laboratory Technician)
Tested raw material and formulation solutions such as pH, absorption and
titrations (acid & base); tested sulfuric acid finish product catalyst such as gas
chromatography, hardness and density; used LIMS software for data entry;
followed OSHA safety and chemical refinery procedures.
Computer Skills: SAP, Excel, Word, Pivot Table/Charts, Powerpoint, BPCS,
Trackwise, EMSS, Spreadsheets, LIMS, etc.
Equipment: Intregrity Tester, DCS, Conductivity Meter, Validator 2000, Soft wall
and rigid wall Isolators, Biolog Identification System, Vitek Identification System,
Autoclave, Biological Safety Hoods, Microscope, PH meter, Climet particle
counter, balance scale, pipettes, air velocity probe, RCS & SAS air sampler and
activity tester for gas chromatography.
References: Upon Request.
Contact this candidate