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QC Technician

Location:
San Diego, CA
Posted:
December 22, 2018

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Resume:

Slava Bagat 858-***-**** ac708h@r.postjobfree.com

PROFESSIONAL SUMMARY

Preparation of stock solutions and buffers following SOPs

Review of production work orders to completion

Quantitative and Qualitative analytical methods to test raw materials and product

Using spectrophotometer, conductivity meter, pH meter

Calibration and maintenance of basic laboratory equipment

Experience working in FDA, GMP-compliant biomanufacturing environment

Aseptic processing in ISO 5 biosafety cabinets (BSC) and ISO 7 clean room environment

Mammalian /human cell culture maintaining and passaging, cell counting using hemocytometer and Vi-Cell counter; Using micropipettes and pipettes for cell processing; Morphology testing, harvesting, seeding and feeding; Using sterile techniques during manual processing in BSC and automated cell processing according to SOPs; Documentation of process in assigned Batch Records following GDP; Monitoring and optimizing of cell culture process equipment performance; Reagent preparation and storage

Knowledge of in vitro molecular biology techniques: SDS PAGE and Agarose Gel Electrophoresis, PCR, Western Blotting, ELISA, Separation of proteins by Size Exclusion and Ion Exchange chromatography, and HPLC

Computer skills: Microsoft Office (Excel, Outlook, PowerPoint, Word)

EDUCATION

MiraCosta College, Oceanside, CA

Biotechnology Laboratory Skills and Bioprocess Technology Certificates Completion

June 2016

San Diego State University, San Diego, CA

Medical Microbiology course and Clinical Hematology laboratory course

2013

Clinical Hematology Course

2012

Simferopol State University, Simferopol, Ukraine

1993-1998

Bachelors & Masters Degrees in Biology; Teaching Degree in Biology/Chemistry

EXPERIENCE

QC Laboratory Technician, Sterogene Bioseparations, Carlsbad, Ca

Prepare stock solutions and buffers. Routine tests and release of raw materials and chemicals. In process and final product testing. Liquid size exclusion chromatography, volumetric/coulometric titrations, protein binding capacity of chromatography resins. Using spectrophotometer, conductivity meter, pH meter, Analysis of test results by comparing to Product and Raw Materials Specifications. Processing Non-Conforming Materials. Perform testing and data analysis for validation. Process nonconforming materials. Environmental monitoring using GMP and GLP practice, bioburden control by swab methods, air sampling of manufacturing facilities. Initiation of Document Change Request. Complete Product and Raw Materials Inventory. Maintain and calibrate or submit instruments for calibration.

Collaborate with various departments to improve product quality by providing feedback and testing. Manage chemical inventory and Hazardous Waste Program.

Manufacturing Technician I, Organogenesis, La Jolla, Ca

Perform work in a clean room environment; Good Manufacturing Practices (GMP) and clean room safety practices and procedures; Cell expansion, follow written SOPs and documenting the manufacturing process in the Batch Record; daily culturing and maintenance of mammal cell culture, cell feeding, harvesting, seeding and counting using manual and automated methods; excellent aseptic processing techniques; Verify forms and documents to completion, Assist with review of Batch Records and processing forms; Assist with writing Batch Records for manufacturing processes; Maintain facility audit-ready; Perform housekeeping on and prepare equipment for calibration and maintenance, and monitor proper working of equipment; Submit samples to QC; Support R&D team by maintaining cell cultures

Volunteer Work:

Carmel Del Mar School, Del Mar, CA

Organized student paperwork into files; assisted teacher in running class events

Oct.2017-Present

Jul.2016-Oct. 2017

2012-2016

Saint Mary’s Hospital, Livonia, MI

Assisted medical personnel at the front desk; answered phone calls

Helped to maintain residential rooms in the emergency department

2005-2006

Overseas Employment:

Medical Equipment Coordinator; Medical Service Company of Crimea, Simferopol, Ukraine

Responsible for storage and supply of eye care department with medical equipment, reagents and materials

1999-2003



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