Quality Control Assurance
Resume:
Kathy Kong
Email: *********@********.***
Address: **** ******** ***.
City: San Bruno
State: CA
Zip: 94066
Country: USA
Phone: 847-***-****
Skill Level: Experienced
Salary Range: $60,000
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
Permanent:
Kathy Kong
1001 National Ave. #232
San Bruno, CA 94066
******@*******.***
Education: B.S.-Biological Sciences, Minor in Chemistry, Awarded 2003
University of Illinois at Chicago
Experience:
Eurofins Lancaster Laboratories
Microbiologist- Sept 2010 Aug 2012
- Agar diffusion Assay for various antibiotic concentrations in Medicated Animal Feeds
-Authored and revised QC Standard Operating Procedures, as necessary
-Initiated and executed Validation Method Protocols on various formulation of pharmaceutical products
-Execution of the Validation Method Protocols
-Authored and executed Equipment Validation of various equipment in the Quality Control laboratories
Whirlpool Corporation: Research &Engineering Center
Technician: Contractor Sept 2009-Sept 2010
-Global Water Group
-New Methods& Development of Technologies associated with Water Reuse System
Morton Grove Pharmaceuticals, Inc Feb 2007-Aug 2009
Quality Control Analyst- Microbiologist
-Microbial Limits Testing of raw materials, in-process, and finished products
-QC Stability Sample Testing
-Microbial Monitoring of purified water
-Monitoring and replacement of Laboratory Purified Water System Beds and Sanitization Procedure
-Environmental Air Monitoring/Compressed Air Testing
-Preparation of stock cultures and suspensions
-Anti-Microbial Effectiveness Testing
-Microbiological Agar Diffusion Plate Method for Nystatin Assay
-Operation of the HotPack 273700 Low Skin Temperature Vacuum oven and the Welch 8920 Vacuum Pump.
-Standardization and Operation of the Fisher Scientific Model AR50 pH meter in QC laboratories.
-Operation and maintenance of the Microbiology Easter Services Autoclave.
-Microbial identification and characterization of Microorganisms.
-Investigation and reporting of Deviations/Out of Specification Results
-Execution of process Validation Protocols
Pharmaceutical Systems, Inc Dec 2003- Feb 2007
Laboratory Scientist
-Initiated a R&D protocol, The Comparison of Petrifilm plates versus RODAC plates
-Operation of the La Calhene Isolator System, Three Glove Transfer and Half Suit Isolators, for Sterility Testing
-The use of Steritest Compact Units for sterility testing
-BI testing
-Daily reads on Sterility Results
-Environmental Monitoring of Controlled Environment
-Sterility Reports
-Gowning in Class 10,000 and 100,000 Sterility suites
-Direct Transfer of various products
-Operation of Clarus Hydrogen Peroxide Gas Generator
-Environmental Monitoring including surface sampling/Total air particulate monitoring in the GMP environment
-Water Monitoring program for clean steam condensate, AWI, HWI, Purified, and Potable water in the GMP environment.
-Bioburden Assay
-Use of Tracking System (LIMS and custodE-EM& water/results Entry/Task approval)
ID lab:
- Use and maintenance of RiboPrinter microbial characterization system
-Gram-stains
-API 20 NE Test System for the Identification of Gram-negative bacteria from samples such as Environmental Monitoring, In-process, ATCC Microorganisms.
-API STAPH System for the identification of Staphylococcus, Micrococcus, and Kocuria species from samples such as Environmental Monitoring, In-Process, and ATCC microorganisms.
-Identification of Gram positive rods and Gram positive cocci isolates using the BBL Crystal Gram Positive Identification system.
-Identification of Bacterial and Fungal isolates using the Biolog Omnilog Plus Identification System.
Quality Operations-Quality Associate
-General QA work
-Preparation/issuance control and review of SOPs and Controlled Forms.
-Kept in track of deviations and work orders
-Assisted on Client/FDA audits
-Document Control
-Quality Assurance reviews on protocols, SOPs, and reports
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