Quality Assurance Engineer
Resume:
Title:QA/QC SUPERVISOR
abpxa3@r.postjobfree.com
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NAME: CINDY BALCITA
ADDRESS:
CITY: Sonora
STATE/PROVINCE: CA
ZIP/POSTAL CODE: 95370
COUNTRY: USA
EMAIL: abpxa3@r.postjobfree.com
PHONE: 209-***-****
CANDIDATE ID: N/A
CITIZENSHIP: US
Citizen
EDUCATION: Not Entered
EXPERIENCE: Not Entered
WILL RELOCATE: Not Entered
RELOCATION INFO: Not Entered
JOB WANTED: Not Entered
HOMEPAGE:
HOTSKILLS:
ESUME
CINDY T. BALCITA
13040 Mountain View Road
Sonora, CA 95370
Fax: 209-***-****
abpxa3@r.postjobfree.com
CAREER SUMMARY
Microbiologist/Chemist with 20 years of broad-based experience, from
clinical lab to
industrial bio-medical and research and development, environmental
health and
hazardous waste. Scale-up projects, pilot production in manufacturing,
emphasizing
SOP, QA/QC document development, 21 CFR 820 (1997), FDA - Class II &
III Device
cGMP's, USP 1994, ANSI/ASTM/ASQC, ISO 9001:1994. A goal-oriented, team
player
with strong interpersonal skills. Supervised up to 20 employees.
PROFESSIONAL HIGHLIGHTS
1998
-QA/QC SUPERVISOR-REGULATORY AFFAIRS SIERRA DIAGNOSTICS, INC
.
1997
-1999 Sonora, California
Entry level QA/QC Microbiologist. Initiate all phases of propagation,
harvesting/aseptic filling, labeling/packaging mutant N. gonorrhea.
Successfully expanded in-process intermediate testing and final
product performance
assays, developing SOP'S for manufacturing personnel. Initiated new
employee
training and safey programs to comply with GLP, OSHA, Prop 65 and MSDS
inclusive.
Environmental monitoring of Class 10,000 clean room included viable
surface and air
borne monitoring and non-viable particle counts with subsequent API
identification.
Incoming raw material and media evaluation and release, worked
independently
recognizing and prioritizing status of manufacturing schedule to
coincide with QA/QC.
Sterility testing, growth promotion. Developed,documented and
implemented in-house
culture procedures for USP organisms reducing yearly procurement by
$8,000.
Documentation development, implementation and auditing of all
documents compliant
with cGMP, FDA 21 CFR 820.
Maintain operation, preventative maintenance and calibration of all
equipment;
generators, incubators, climat particle counter, SAS air sampler, ph
meters,
autoclaves, dry heat ovens, vacuum pumps were just a few.
Regulatory affairs liaison for County and State environmental health
agencies
reporting and updating medical waste and hazardous chemical
invensponsible for the design
development and validation of quality systems for supplier quality
management and
vehicle performance production lines.
Developed and evaluated R&D vehicle assembly processes, in a high
volume Just in
Time production environment.
Evaluated supplier inspection standards, mitigating associated risks
and costs of
accepting poor quality lots into a high volume just in time
manufacturing environment.
Managed various supplier projects to assure quality certification
and compliance.
Drove improvements in quality by encouraging a team oriented
philosophy in
manufacturing.
Trained production line workers on prototype production equipment
and processes.
Created and updated various manufacturing instruction procedures for
production and
quality control.
Developed packaging requirements for component transportation and
storage.
Coordinated the installation of equipment and subcontracting for new
vehicle
performance assembly lines.
Managed the introduction/modifications of new products and processes
in various
areas of production.
General Signal Thin Film Corporation
- Fremont, CA - Quality Assurance
Test
Engineer, ( 1/90 - 6/91) Quality Assurance Test Engineer responsible
for the testing,
quality certification and customer compliance of semiconductor capital
equipment.
Tested and certified semiconductor capital equipment before off site
shipment to a
customer.
Implemented and developed test procedures for the certification of
semiconductor
equipment in a wafer fab environment.
Supported and trained manufacturing workers in identifying and
testing for quality
related issues on production equipment and manufacturing processes.
Conducted supplier audits to determine supplier capabilities for
supplying test
equipment and components.
Becton Dickenson Corporation
- San Jose CA - Manufacturing Engineer -
( 6/87
- 1/90
)
Manufacturing engineer
responsible for the testing and evaluation of
flow cytometry
equipment in a R&D biomedical environment.
Designed and developed quality standards for product diagnostic
certification.
Qualified and deployed proto-type flow cytometry equipment into both
laboratory and
production environments.
Designed and deployed various test procedures for standardized work
practices.
Trained and supported manufacturing on the understanding,
utilization and
manufacturing of flow cytometry equipment.
Provided strong trouble shooting assistance to manufacturing in
resolving quality
related issues which directly impacted yields.
EDUCATION
Master of Science
: Quality Assurance, San Jose State University.
Bachelor Of Science
- Electrical Engineering - Devry Institute of
Technology
i
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