Resume: Quality / Validation Engineering Contractor / Subcontractor
Dr. Robby Gordon
drgordon34 at aol.com
Wed Oct 11 15:22:38 EST 2000
Please view my site for more information -> http://qeval.homestead.com
Providing work as any of the following:
* ISO / OSHA / GMP / QSR / QS / DEA / FDA (facility / documentation /
validation) - AUDITOR
* Industrial Hygienist
* Design Control Specialist (FMEA, FTA, hazard analysis)
* MRP / ERP developer
* Quality / Validation Engineer
* Quality Assurance Specialist
* Technical Writer
* Regulatory Specialist Specialist
* CE Marking Specialist
Working for these industries:
* Medical Devices
* Information Technology
Just some of the things I can do for your company:
1. Reduction in Quality Costs.
2. Enhancement in Quality Practices.
3. Enhancement in Research Techniques.
4. Reduction in wasted labor and material.
5. Satisfaction of Federal and Local Government compliance in
6. Introduction of new technologies, techniques and innovations.
7. Increase in speed, safety and efficiency.
In the end what all this means to you:
1. Increased inter and intra-departmental performance.
2. Increased Profit.
3. Increased Customer Satisfaction.
4. Reduced wasted capital, time and effort.
Cezar is not intimidated by projects outside his area of expertise. He
is motivated, energetic, and resourceful. Cezar will excel in any
environment. I am greatful that he is on my team.
Grace Kwan, Director of Quality & Regulatory Affairs at QDI
There were times when work was chaotic and overwhelming, but his
perseverance and cunning had always prevailed... He
seems to be always sharp and in the lead. He is ambitious and there seems
to be no obstacle that he cannot overcome...
Dr. Robert Gordon PFP,VMD, http://www.monetarystress.com
Cezar is a self starter and always insured that his projects were
completed on time. His communication skills are excellent and he also
helped with departmental training. In addition to his professional
activities, Cezar is very active in many community causes, which he donates
his time working with kids. Cezar's dedication to his job, motivation and
job knowledge makes him a wonderful candidate for future career challenges.
Nannette Monreal MSQA, V.P. of Quality Assurance, Leiner Health Products
Resume Page -> http://qeval.homestead.com/resume.html
Skills Page -> http://qeval.homestead.com/skills.html
References Page -> http://qeval.homestead.com/references.html
Validations Completed -> http://qeval.homestead.com/MyValidations.html
Letters of Recommendation -> http://qeval.homestead.com/testimonial.html
My approach to projects -> http://qeval.homestead.com/testimonial.html
Type of Services provided -> http://qeval.homestead.com/service.html
My rates and conditions -> http://qeval.homestead.com/salary.html
qeval2000 at yahoo.com http://qeval.homestead.com
OBJECTIVE: To provide professional consulting services.
Competencies: cGMP/GLP/OSHA/QSRValidations Material Control / Inspections /
Internal / Vendor Audits Metrology / Maint. Product Failure analysis /
IT Management Personnel Training Environmental / Micro. / Chem.
Pharmaceuticals Solids / Semisolids Medical Devices (I,II, III) / IVDs
NRC / Nuclear Env Ctrl PLC / Sftwr. Val. FMEA / FTA / Design Controls
MBI / UroCor through Perigon / PTS, Oklahoma City, OK6/00 - 7/00
Quality Assurance / Validation Specialist -
MBI / UroCor is a medical device manufacturer of
nuclear sources implants. Supported all Quality Assurance and Validation
functions. Wrote, SOP's for quality assurance, maintenance, calibration,
and use of equipment. Management: Stanley Mills PhD, Jacqueline Mills,
Tarance Grisso, David Caravaglio.
OSHA / IH facility audits and corrective action implement. SOP generation
and revision (20+)
Internal GMP, Documentation and Facility Audits Design Control Development
Project planning for quality issues, PLC and Software Vals. FMEA / FTA /
Managed, created, executed and summarized Equipment and Process
Validations Trained personnel in QSR, GMP, OSHA, design ctrls, latest FDA
Oread Pharmaceuticals through QST / Oxford, Palo Alto, CA2/00 - 6/00
Quality Assurance / Validation Specialist -
Oread is a contract pharmaceutical manufacturer of
parenterals, liquid, semi-solid, and solid dose drugs. Supported any
Quality Assurance and Validation functions for contract manufacturer.
Supported technology transfer. Projects were performed for clients such
as: ICN, Roche, Agouron, Praecis, BioMedicines, Guilford, Nissan, Dura,
Unimed and Xoma. Management: Beth Rice, Marji Prows, Tony Brown, Ken Miles
PhD, Arlene Blakes.
Equipment and Process Validations SOP generation and revision
Cleaning Validations Batch Verification
Stability Trending Audit Responses
Internal GMP, Documentation and Facility Audits Investigations /
Qualisys Diagnostics, Inc. Irvine / Carlsbad, CA11/98 - 1/00
Quality Engineer / Product Support Lead / IT Support
Qualisys / Qualigen is an IVD manufacturer for
immunoassay kits by means of electronic assaying devices. Validated lab and
manufacturing equipment, test methods, facility, and mnfg processes.
Oversaw V&V and design transfer. Technical training and assistance.
Supplier and vendor audits. CPA, MRB, Quarantine and Approval process.
Purchasing (over $750K), receiving, and inspections. Control of material
via MRP system. Database development. Industrial hygiene, safety and GLP
establishment. Metrology and basic maintenance. Implemented QSR's and
ISO9000's to all phases. Heavy technical and computer support and
development. Supervisor: Grace Kwan, Glenn Walker, Gary Alvey.
IQ,OQ,PQ execution and protocol generation / V&V SOP generation and
DOE & statistics in clinicals, validation and manufacturing Internal &
PMA & 510K assistance / stability management Metrology & Maintenance
Personnel training (QSR's, GLP's, cGMP's, computer) Material Management /
Allergan (R&D dept.) (through Kimtec)
Validations Specialist Contractor
Allergan - equipment val. / SOP's / validation records audit 9/98 - 10/98
B. Braun | McGaw, Validations / QE Dept., Irvine 4/97 - 8/98
Quality Engineer Associate II
B.Braun | McGaw is a manufacturer of paranteral
pharmaceuticals and medical devices. Validated/requalified systems, new or
revised products, systems, PLC's, and facilities. Investigated product
complaints. Technical training and assistance. Performed plant shutdown
operations. Supervisor: Nannette Monreal & John Smith / previously Blair
IQ,OQ,PQ execution and protocol generation SOP generation and revision
Chairing of product eval. and plant coordination meetings DOE, R&R,
Stats. and Mil. Std's
Personnel training (validations, requal, computer, app., etc.) Facility
Allergan (QC dept.) (through Lab Support), Irvine
12/96 - 4/97
Environmental Monitoring Microbiology Laboratory /
Allergan is a munufacturer of pharmaceuticals,
medical devices, and cosmetics. Performed environmental monitoring and
chemical analysis. Endotoxin testing of medical devices. 209E forms and
trending. Supervisor: Rod Patterson
Viable testing of water, air, and surfaces. LAL (clot) testing on devices
Gas Chromatography / IR Spectorscopy Non-viable testing of air.
McGaw (QC dept.) (through Lab Support), Irvine3/96 - 11/96 (f/t) & 11/96 -
Environmental Monitoring Technician / Media and
McGaw is a manufacturer of paranteral
pharmaceuticals and medical devices. Performed environmental monitoring.
Assisted in sterility testing of final product. Led investigations and
performed trending. Supervisors: Myron Civils & Wendy Ricapito
Viable testing of water, air, and surfaces.Non-viable testing of air
Applications/O.S.: DOS, SigmaStat, SigmaPlot, some UNIX, Access,
Windows2000/95/3.X/NT, Excel, Word, BASIC, Power Point, Lotus Notes &
Organizer, LIMS, Statgraphics, Mathematica 2.2, Harvard Graphics, Project,
TurboCAD 6.0, CorelDraw, network (Novell)
LANGUAGES Basics: Spanish and French
EDUCATION: B.S. Biological Sciences, specializing in
microbiology, emphasis in chemistry and psychology.
University of California at Irvine.
Tasks at Qualisys Diagnostics, Inc.
Class II level medical device diagnostics manufacturing facility
1. Quality and Validations Engineering
1.1. Design of Experiment
1.1.1. Conducting own experiments
1.1.2. Taguchi methodology
1.1.3. Process capability, normality analysis, and sample analysis.
1.2. Product design improvements planning
1.3. Product and raw material prospective evaluation.
1.4. Statistical Process Capability (SPC) charting.
1.5. Statistical Quality Control (SQC) implementation.
1.6. FMEA, FTA, HA (Failure Modes and Effects Analysis, Fault Tree
Analysis, Hazard Analysis)
1.7. Feasibility and Stability runs.
126.96.36.199. Lab Equipment and production equipment
188.8.131.52. Test Method validations
184.108.40.206. Process Validations
220.127.116.11. Validations & Verifications - assisted outside
contractors with software validations.
2.1. Training personnel in QSR, cGMP's, GLP, OSHA and ISO9000's
2.2. Computer applications training.
3. Information and Technical Systems
3.1. Customized databases for collecting and controlling information from
instrumentation, metrology, maintenance, documentation, purchased chemical
control, indentured lists, and other controlled systems.
3.2. All aspects in rolling in new systems and peripherals.
3.3. All technical support - (hardware and software)
3.4. Programming (Excel, Access, and VBA related)
3.6. Training and assistance
3.6.1. Word, Excel, Access, Win95/98/NT, Project, Luminometer software,
3.6.2. Rosys Anthos Robotics (AutoLucy)
4. Production and Process Engineering
4.1. Making suggestions for improvement of process.
4.2. Implementing facility design into projected product production area
4.3. Challenging designed process plans.
4.4. Feasibility runs.
5.1. Revision of existing SOP's and generation of new.
6. Incoming Material Inspection
6.1. Development of database tracking system.
6.2. Development and implementation of labeling system.
6.3. Development of QC sampling and testing, stability retention,
approval, quarantine, MRB assignment.
7.1. Responsible for tracking and purchasing lab supplies, information,
7.1.1. Responsible for over $750,000 purchased in capital.
7.1.2. Budgeting purchases
7.1.3. Correspondence with suppliers
18.104.22.168. VWR, Scientific Products, Fisher, OHAUS, Omega, etc.
8. Inventory Control
9. Quality Assurance
9.1. Certification of new suppliers/vendors.
9.2. Purchased Chemical Control
9.3. Supporting two 510(k) processes and a PMA.
9.4. CE mark and MDD (Medical Device Directive) support.
9.4. Industrial Hygiene and Safety:
9.4.1. Have created and implementing the following:
22.214.171.124. Biohazard program with blood-borne pathogens
126.96.36.199. Waste management program, identification and
188.8.131.52. GLP's and all associated safety mechanisms
184.108.40.206. Fire safety program and documentation
220.127.116.11. Emergency evacuation program
18.104.22.168. EPA (Hazardous Waste and OSHA regulations).
10.1. Corresponding with local contracting agencies in
the implementation of calibration system.
10.2. Assuring NIST traceability is maintained with all
10.3. Exploring cost vs. in house calibration
10.3.1. Implementing Handbook 44 and 130 in calibration procedures.
10.4. Accounting all equipment is traced and applicable
calibration schedule is maintained.
10.5. Performed Calibration and R&R.
10.5.5. Graduated Cylinders
11. Maintenance (preventive and emergency)
11.1. Creating and implementing of maintenance program
for lab equipment and production equipment as they are being acquired.
Quality / Validation Engineering - B Braun | McGaw
· Product complaints investigation - Product Service/Incidence Report
· Decontamination processing of returned product (hazardous materials
· Physical evaluation
· Coordination of product testing with laboratories (e.g. chemistry,
microbiological, BTC, engineering, etc.)
· Summarization of laboratory results in technical reports
· Issuance of corrective action if applicable
· Identifying areas of common product issues
· Presenting suggestions for product improvement and trend analysis
· Validations (Installation, Operational, and Performance Qualification)
· PLC, systems (retrospective), facilities, equipment and product
· Protocol generation and execution
· Coordination of validations with applicable departments
· Validation summarization
· Product Test Run Authorization execution and creation of testing method
· Some - Design of Experiment generation, coordination and execution
· Statistical evaluation with respect to Cpk, confidence level, military
· Final deposition of product based upon the statistical evaluation and
· Quality Control Release Verification (QCRV) coordination
· Review of Maintenance Orders and assignment of Change Control
Validation or QCRV
· Coordination of sampling plans and required testing with laboratories
· Release of classified and controlled facilities,
distilled/deionized/softened water, compressed air, pumps, steam,
sterilizers, etc. upon receipt of applicable data in compliance with company
and government regulations
· Addressing problem facilities/systems/products and identifying trends
· Tracking the maintenance progress and laboratory results
· Meeting presentations - As Acting Chairperson
· Product investigation updates and statistical evaluation
· Validation updates and coordination
· QCRV / Change Control Request coordination meetings with maintenance
department and laboratories
· SOP generation/revision and Document Orders
· Revision of Standard Operating Procedures, Technical Information
· Creation of quantitative sampling plan with aid of mil. standards or
other statistical approach
· Knowledge of Plastics and LVP fabrication / filling
· EXCEL®, DUPLEXT, PAB®, Glass, PICT, Add-A-Vial®, addEASE,
Compounding, SafeLine®, Injection Molding, Blow Molding, Film Extrusion
· Technical Training of Personnel
· Computer training - Windows/NT, Excel, Word, Network (Novell), Lotus
Organizer & Notes
· New Test Methods, Validation, QC Release Verification
· Technical Assistance
· Computer, applications, network, printer and other assistance
· Requalification / Validation approach and procedures
· Internal Audits
· Routine and unscheduled facilities and process audits
· High Involvement Team member
· Involved with teams, in efforts of modernizing and improving specific
aspects of the company
· Infra Red Spectrum analysis - Perkins Elmer
· Liquid and Solid
· Gas Chromotography - Hewlette Packard 6890 II
· Standards and Sample testing
· Obtaining results within a minimum of 99% correlation of obtained
· Maintenance of machine, peripherals, computer, printer, gas delivery,
headspace, gas tanks
· Ultra -violet Spectrum
· pH analysis
· Titration method
· Atomic Absorption analysis
· Western Blotting
· Limulase Amebocyte Lysate (clot) testing of surgical devices
· Auxonographic testing of Antibiotic affectivity
· Bioburden testing of air water, plastics, surgical devices, and
· Filtration and incubated growth on TSA plate
· Heat Shock
· General biochemical ID techniques
· Gram Staining, acid-fast stain, OF-Glucose, Oxidase, Catalase, etc.
· Microbial Enumeration
· Surface testing
· Sterilizer use - Castle / Amsco
· Particulate Matter monitoring in water and air using HIAC or MetOne
· Velocity of air using AIRVELO
· Pressure, temperature, and humidity monitoring
· HEPA hood leak testing
· Data trending
Completed Validations and Sub-Validations
1. QCRV - Quality Control Release Verification
1.1. WFI -water for irrigation lines
1.2. Power Plant
1.2.1. Holding Tank
1.2.4. Compressed Air
1.2.5. Steam and Condensate return lines
1.3. Clean Room repairs and upgrades
2. PTRA - Production Test Run Authorization
2.1. Conveyor PLC change and proximity switch installation
2.2. New Inkjet Printer Installation
2.3. Boxing equipment change and installation
3.1.3. Wash buffer
3.2. Filling Precision and Accuracy
3.3. Pouch Fabrication
3.4. Bag Fabrication
3.5. Bottle injection molding design specifications
4.1.1. Bag washers and rinsers
4.1.2. Washing machines
4.1.4. Component Washers and Driers
4.1.5. Injection molding machines
4.1.6. Film extrude
4.1.7. Blow Molders
4.1.8. Labeling and printing machines
4.1.9. Boxing and ink dispensers
4.1.10. Conveyors and associated mechanisms
4.1.11. Ultrasonic welders
4.1.12. Component assembly machines
4.1.15. Filters (including integrity tests)
4.1.17. Steam, compressed air and WFI lines
22.214.171.124. Against standards
4.2.6. Purified and Deionized water
4.2.7. Bag parallel and cylindrical burst pressure testers
4.2.8. Plunger activation machine
5.1. Compounding Equipment
5.2. Facility Sanitation
6.1. Sterilization Tank Validation assistance
6.1.1. Viable and non viable testing
6.1.2. Pressure and Filter Integrity
6.1.3. Fo Limits - Steam, EtO
6.1.4. BI testing
7.1. Capping machine PLC change
7.2. Bag fabrication Machine
7.2.1. Alarms challenge
7.2.2. Parameter challenge
7.2.3. Proximity switches
7.2.4. Temperature sensors
7.2.5. Environmental Controls
8. V&V (software and hardware)
8.1. FastPack Analyzer
8.1.1. FTA (fault tree analysis)
8.1.2. FMEA (failure mode and Error analysis)
8.1.3. Software Validation assistance
8.2. Equipment and Documentation Control System - Access dBase
8.2.1. FTA (fault tree analysis)
8.2.2. FMEA (failure mode and Error analysis)
9. Test Method Validation
9.1. QC methods
126.96.36.199. Use of calipers in inspections
188.8.131.52. Use of multimeter in inspections
184.108.40.206. Chemiluminescent assay accuracy and precision, using R&R.
220.127.116.11. Streptavidin binding assay.
18.104.22.168. Chemiluminescent substrate accuracy and precision.
10. Facility Audits and Validations
10.1. Power plant
10.1.1. Boiler room
10.1.3. Compressed air
10.1.5. Condensate Return
10.2. HVAC and Air Systems
10.3. Clean Rooms (class 100K to 1K)
10.3.1. Main manufacturing facilities
10.3.2. Gowning Rooms
10.3.4. Transfer Rooms
10.3.4.1. HEPA filtration and integrity
10.3.4.2. Room air change
10.3.4.3. Viable and non-viable air
10.3.4.4. Viable surface
10.3.4.5. Smoke studies
10.3.4.6. Positive Pressure
10.3.4.7. Personnel PM and viable tests.
University of California at Irvine - Bachelor's of Science, Biological
Hazardous Waste Management Training - Allergan, 2/12/97
OSHA Lab Standard Training Course - Allergan, 2/19/97
OCRA (Orange County Regulatory Affairs) FDA IVD Workshop - Irvine CA, 2/2/99
MD&M seminar - BSI registrar and the ISO9000's - Anaheim CA, 2/10/97
cGMP's - McGaw, Inc. (quarterly 1996, 1997 and 1998)
MD&M (Medical Design & Manufacturing) workshops - Anaheim CA, 2/7/99 (0.4
1. Software Verification and Validation of Embedded Systems
2. Design Transfer
3. Process Validation Guidance
4. Defining a Process During the Operational Qualification
5. Making Process Validation Continuous with Process Monitoring
6. Steps to Implement Design Controls
7. Design Controls for Product Development
MIS154B CMGT574 ( CIS Business Communications) - University of Phoenix (3
Skill Name, Skill Level, Last Used, Experience
510k, PMA - Intermediate - Currently used1 years
Access - Expert - Currently used - 4 years
Atomic Absorption Spec. - Intermediate - +4 years ago -
Autolucy / Tecan Anthos Rosys - Beginner - Currently used1
Castle / Amsco Sterilizers - Expert - 1 year ago - 3
CE Marking, MDD, IVDD - Beginner - Currently used - 1
cGMP GLP OSHA QSR ISO9000, 9001 reg's - Expert - Currently
used - 4 years
Cleaning Validations - Expert - Currently used - 3
Comparitor - Intermediate - 2 years ago - 2 years
Corel Draw 7 - Intermediate - Currently used - 1 years
Design Controls, FMEA, FTA, Hazards - ExpertCurrently used -
DOE - Intermediate - Currently used - 1 years
DOS - Expert - Currently used - 9 years
Enzyme Immunoassay Analysis - Beginner - Currently used -
Equipment Validation - Expert - Currently used - 3
Ethernet LAN - Intermediate - Currently used - 2 years
Excel - Expert - Currently used - 7 years
Facility Validations - Expert - Currently used - 3
FPLC (Pharmacia) - Beginner - Currently used - 1 years
Fractionating (Pharmacia) - Beginner - Currently used - 1 years
Fractionator (Pharmacia) - Expert - Currently used - 1 years
French - Intermediate - 3 years ago - 4 years
Gas Chromotography HP6890 II - Expert - 1 year ago - 1 years
HIAC / MetOne PM counters - Expert - 1 year ago - 3 years
HPLC - Waters - Beginner - 1 year ago - 1 years
IBM PC - Expert - Currently used - 13 years
IMx Spectrophotometer - Beginner - Currently used1 years
Instron (fatigue &tension)Beginner2 years ago3 years
Internal / Vendor AuditsExpertCurrently used3 years
IR spectra - Perkins ElmerExpert1 year ago1 years
IT Training and SupportIntermediateCurrently used2 years
LAL (Endotoxin)Intermediate1 year ago2 years
LIMSExpert2 years ago2 years
Lotus Organizer / NotesExpert1 year ago2 years
Material Control / Inspection / InventoryExpertCurrently used2 years
Mathematica 2.2Intermediate3 years ago2 years
Metrology and Basic MaintenanceIntermediateCurrently used1 years
MicrocalipersExpertCurrently used4 years
MS Frontpage 2000ExpertCurrently used1 years
MS OutlookExpertCurrently used2 years
MS ProjectIntermediateCurrently used1 years
Novell NetworksBeginner1 year ago2 years
NRC regulationsIntermediateCurrently used1 years
Oscilloscopes (various)Beginner+4 years ago2 years
Personnel trainingExpertCurrently used3 years
pH / Conductivity Meters (Accumet)ExpertCurrently used4 years
PLC ValidationsIntermediateCurrently used3 years
Polish (& other Slavic/Cyrillic)IntermediateCurrently used25 years
Power PointExpertCurrently used3 years
Process ValidationIntermediateCurrently used3 years
PurchasingIntermediateCurrently used1 years
R&RExpertCurrently used2 years
SigmaStat / SigmaPlotExpertCurrently used1 years
SoftQuad Hotmetal Web Hosting & DesignIntermediateCurrently used1 years
Software ValidationsBeginnerCurrently used1 years
SpanishIntermediateCurrently used5 years
StatgraphicsExpert1 year ago2 years
Sterilization ValidationIntermediate2 years ago2 years
Stratus and Proteus (ERP system)Intermediate2 years ago2 years
StroboscopeExpertCurrently used3 years
TensiometersExpertCurrently used4 years
Test Method ValidationIntermediateCurrently used1 years
TurboCADIntermediateCurrently used1 years
Typing and 10 KeyExpertCurrently used10 years
UNIXIntermediate1 year ago2 years
V&VBeginnerCurrently used1 years
Vendors&Parts (MRP system)ExpertCurrently used1 years
Visual BasicBeginnerCurrently used1 years
Visual Basic for ApplicationsIntermediateCurrently used3 years
Windows 9X/3.X/NTExpertCurrently used7 years
WordExpertCurrently used6 years
Zylux LuminometerExpertCurrently used1 years
Brachytherapy methodologyIntermediateCurrently used1 years
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The Monetary Stress Institute http://www.monetarystress.com - Learn how you
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how to turn conflict into agreement. You will be motivated and inspired to
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* Financial Assistance, Credit, Loans, Funds, and Investing
We help you with your Loans, Lines of Credit, and Financial Planning.
You will take control of your personal and business financial future. In
order to provide a full spectrum of financial services to his clientele, Dr.
Gordon developed expertise in real estate loans and lines of credit for
Eleanor S. Field, PhD - http://www.doctorelly.com Director, A Center For
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Psychologist and Author, Marriage & Family Therapist Hypnotherapist. Dr.
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Anxiety/Panic * Auto-Immune Disorders * Business Consulting
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* Website Design, Computer Assistance, E-commerce
http://webdesignplus.homestead.com Corporate & Private Web Site designing.
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Service way below market price
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Upgrades of your existing system and Setup.
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* Physical Health
Danzan Ryu Jujitsu - http://ocjujitsu.homestead.com
Hi No De Ryu - Orange YMCA
Orange YMCA provides Jujitsu junior and senior classes
* Professional Services
Network of Professionals - http://www.networkofprofessionals.com/
We are a network of Professionals in the areas of Statistics, Information
Systems, Engineering, Chemistry, Microbiology, Toxicology, Quality
Assurance, Regulatory Affairs, and Mechanical & Electrical maintenance /
Providing the industries and enterprises with the most innovative and
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You do not have any time to waste on searching and experiencing an
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Providing you with excellent services and products for metrology.
Thermometers, thermocouple, pippettes, balances, strobes, etc.
http://www.iso9001compliance.com/af.cfm?af_id=35 - ISO 9001 Compliance
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recommended to you
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