Microbiologist

KORNELIA M. GRZYBOWSKA

Authorized to work in the U.S. without sponsorship

** ******** *******, ***. ***

New Rochelle, NY 10801

Phone number: (917) 796 – 8263

****.**********@*****.***

www.linkedin.com/in/korneliagrzybowska

PROFILE

QC/QA Specialist oriented to work for Fortune 500 companies

13+ years experience in laboratories and quality departments

Strong knowledge of quality requirements as well as skill of microbiology, techniques molecular biology, hematology and biochemistry

WORK EXPERIENCE

Adamed Ltd., Warsaw, Poland (one of leading pharmaceutical company) 2001 – 2010

Twice awarded a prize for the best worker (2006 and 2008)

QA Specialist/Auditor 2007 – 2010

• Implementation and maintenance of quality systems (GMP, ISO) according to international requirements and company standards

• Author of more than 100 SOPs, instructions, protocols, reports for quality processes

• Author and supervisor of Validation Master Plans and validation/qualification procedures created in accordance with Annex 15 to the EU Guide to Good Manufacturing Practice

• Performed 10 prospective and retrospective validations of manufacturing processes during

3 years

• Developed standard control of trends of microbiological results from "clean" areas in company, including reaction procedures

• Reviewer of manufacturing documentation (in-process records, batch forms, equipments calibration)

• Participated in around 30 internal and 6 external audits of quality including foreign facilities

QC Analyst, Microbiology 2001 – 2007

• Participated in creating Laboratory of Microbiology in Quality Control Department

• Built and implemented quality system in laboratory according to GMP and GLP requirements

• Around 1500 microbiology tests per year of final products, products in bulk, raw materials

• Overview, analysis and evaluation of test results in laboratory

• 30 microbiological controls per year in production area ("in-process" monitoring of personnel, environment, equipment and water)

• Managed implementation and developed trend analysis in production environment and laboratories

Molecular Diagnostic Laboratory “Medigen”, Warsaw, Poland 1999 - 2000

Medical Analysis Technician

• Prepared and followed analyses of HLA antigens, test of RNA HCV, CMV and HPV antibodies

• Controlled reagents for blood tests

• Ordered test reagents

• Prepared all laboratory equipment used for tests

Institute of Hematology and Transfusion in Warsaw, Poland 1997 - 1999

Department of Molecular Biology

Medical Analysis Technician

• Performed laboratory tests for HLA antigens

• Prepared standards and reagents to detect RNA HCV, HIV antibodies and others molecular tests

• Controlled reagents for blood tests

EDUCATION

2003 - 2004 Postgraduate study Microbiology, Hygiene and Quality in Industry“

Technical University of Lodz, Faculty of Biotechnology and Food Sciences

1997 - 2002 Master of Science - Biology

University of Podlasie in Siedlce, Faculty of Biology

1994 - 1996 Certificate of Medical Analysis Technician

Medical Vocational School in Warsaw

TRAINING

2002 – 2009 Series of trainings on improvement of quality systems in the pharmaceutical industry prepared by School of Good Manufacturing Practice for Medicinal Products and Medical Devices

2005 – 2006 Five-step training for Internal Auditors in Polish Chamber of Pharmaceutical Industries and Medical Devices Polfarmed

2002 - 2005 Trainings of the quality and performance of systems in microbiology laboratories performed by Water Foundation in Gdansk

2002 Quality management system in the laboratory according to EN ISO 17025

OTHER SKILLS

Polish – native, working knowledge of Russian

US driver’s license

Strong Microsoft Office Suite skills (Word, Excel, and PowerPoint)

Voluntary Educator of girls groups in Catholic Youth Organization

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