Birth : Warsaw, Poland 1972 Citizen : Polish and USA Passport : Polish and USA Civil Status : Not-married Year Work Started : 1995 Address : 13 Lassen Irvine, CA 92612 Job Sector: Quality – Pharmaceutical, Medical Devices, Biotechnology and Information Technology.

EDUCATION:

University of California at Irvine – USA: B.S. (Bachelor of Science) - Biological Sciences (specializing in microbiology and chemistry) 1990 - 1995.

University of California at Irvine – USA: A.S. (Associate of Science) – Psychology 1990 - 1992.

* Please visit my website for detailed and in depth analysis of my work at www.qualityleader.com

SKILLS & QUALIFICATIONS :

Information Technology:

Software/O.S.: DOS, UNIX, Novell, Windows2000/95/3.X/NT/XP/Me, Access, Excel, Word, Power Point, Outlook, Adobe Acrobat, Project, Visio, Crystal Reports, Lotus Notes & Organizer, Statgraphics, Statistica, SigmaStat, SigmaPlot, Mathematica 2.2, TurboCAD 6.0.

EDMS/LIMS: MetaPhase / MetaWeb, Documentum, Stratus, SQL-LIMS, CATsWeb

Programming: BASIC, VBA, some Rockwell RSLogix ladder logic and LabView

ERP / MRP: MfgPRO, Proteus, Stratus, Vendors&PRO

Regulations / Standards:

USA: GMP - FDA 21CFR-Part 211, GLP (21CFR Part 58, QSR (21CFR Part 820), ERES (21CFR – Part 11), MIL-STD-105E, ANSI/ASQC Z1.4/Z1.9-1993

EU : EMEA GMP – 91/412/EEC & 91/356/EEC

Universal: ISO9000:1994/2000, 9001, 9002, ISO13485, ISO TC 209-14698, EN45001/ISO17025

Languages: Native: English / Polish Conversational: French / Spanish

EXPERIENCE:

Applied Medical, R. Santa Margarita, CA

Feb 06 - present

SAP Validation Engineer

Develop all GAMP required SDLC documentation for validation of SAP modules in CA, Europe, and Australia. Development of blueprints, landscape design, technical architecture, system requirements specifications, functional design specifications, risk analysis, traceability matrix, unit/integration test scripts and other supporting documentation. Train team on GMP/GDP/ISO/QSR/EMEA regulatory needs and validation process. Validation of the WM & RF Barcoding, FICO, MM, PP, SD, CO, and FI modules. WLAN &RF site survey and stress testing. Develop, maintain, and track validation plan. Client contact: Cheryl Blake

Dendreon, Seattle, WA

May 05 - present

Quality Engineer / Biostatistician

Provided statistical support for developing approach, performing analysis, Design of Experiments, determination of sample size, number of runs, and setting acceptance criteria for Provenge vaccine Process Validation and manufacturing. Evaluated statistically molecular, cellular, and protein data for IND/NDA submission to the FDA (with a successful approval) and Provide Quality Engineering support for developing cleaning validation approach for Commercial Immunotherapy Manufacturing Facilities. Developed Risk Analysis and FMEA database, system, documentation and full evaluation of manufacturing processes. Supported Biostatistics department. Provided general statistical training. Client contact: Covington Michael, Dr. Suleman Verjee.

Intralase, Irvine, CA

Nov 00 – Dec 03 / Jan 05 – Jun 05

Quality Engineer / Validation Specialist Consultant

Supported all Quality Assurance and Validation functions. Part 11 compliance, validations and V&V. Performed Facility validations. Client contact: Judy Gordon, Sheila Nyberg, and Lynda Jeffcoat.

STAAR Surgical, Monrovia / Aliso Viejo, CA

Sep 2004 – Jun 05

Validation Consultant

Validated ovens, sterilizers, and heat sealers. Validated processes. Generated validation protocols, use, maintenance, and calibration SOPs. Created Designs of Experiment (DOE) / Engineering Study on equipment / processes. Provided statistical analysis, review and process prediction.

MicroConstants, San Diego, CA

Jan 2005 – Feb 2005

Part 11 Consultant

GAP Audit and remediation plan for their 19 HPLC, GC, Mass Spec’s, PC, Temp Monitoring SCADA (Kaye LabWatch), Sever, LAN and documentation. Training in 21CFR Part 11 compliance. Report of findings.

Vétoquinol / Biowet, Lure France / Gorzów Wielk. Poland

May - Aug 2004

Production & Tech. Transfer Consultant

Assisted in providing strategies / methods for technology transfer from Switzerland and France to production in Eastern Europe with reference to 91/412/EEC.

Irvine Scientific, Irvine, CA

Mar - Apr 04 / Sep 04 – Oct 04

Part-11 Validation Consultant

Validated Blue Mountain Calibration System 4.0. Planned master validation for in-house databases and DataStream MP2. Created proposals and coordinated validations activities with IT (Computer) department. Coordinated discounts with software vendor.

SynCo Biopartners / Brunel, Amsterdam, Holland

November 2003

Part 11 Validations and GLP Consultant

Provided training in Electronic Documentation Systems and validation requirements. Provided project plan for implementation and qualification of Electronic Documentation Management System (EDMS). Provided project plan for implementation of Good Laboratory Practices (21CFR Part 58 - GLP’s).

BioChem, Bologna, Italy

October 2003

GLP Consultant

Provided in-house training for GLP and Good Manufacturing Practices (21CFR Part 211 - GMP’s). Strategized laboratory layout and processes.

Charles Ischi AG, Zuchwil, Switzerland

October 2003

GMP Consultant

Provided strategy and guidance for US-GMP implementation. Created project plan and master validation plan.

MDS Pharma, Paris, France

September 2003

Part-11 / ERES* Validations Consultant

Provided project management concepts for qualification of computerized & automated systems in USA, Canada and Europe. * ERES= Electronic Records & Electronic Signatures & Good Automated Manufacturing Practices (GAMP).

Baxter BioScience, Glendale & WLV, CA

March 02 – October 03

Business Analyst & Part 11 / Global ERES Compliance Consultant

Assessed Gap and Part 11 (ERES) compliance over many US and International facilities. Researched best ERES solutions / technologies for Part 11 compliance, global implementation, user friendliness, and budget capability. Global ERES budget analysis & application. Developed Validation / Software Development Life Cycle (SDLC) documentation for computerized systems and software. Provided support for implementation & completion of Corporate Charter. Client contact: Michael E. Thompson and Christoph Ehrendorfer

AulaGMP, Barcelona, Spain

October 2002

Speaking Presentation / Seminar Instructor

Researched and created courses in English but customized for Spanish speaking professionals. Presented on two topics Auditing of Micro QC Lab and Validation of Laboratory Equipment in an FDA Environment (see below). Power Point presentations at: http://qeval.homestead.com/resume.html

Pharmaceutical Training Inst. (PTI), NYC, NY

November 2002

Speaking Presentations / Seminar Instructor – Validation of Laboratory Instruments

Created a course for the topic of Lab Instruments with emphasis on ERES compliance, ehanced with workshops to show SDLC development. Power Point presentations at: http://qeval.homestead.com/resume.html

LG Life Science / Management Services Int’l, Iksan, Korea

September 2002

Part 11 Compliance Consultant

Assessed Gap and ERES compliance at LG-LS. Created report of the evaluation. Made introduction and exit presentations. Presented Gap analysis results and suggestions. Planned multi-million dollar plan for ERES / remediation. Client Contact: MSI – David Parker.

Intn’l Qual & Productivity Ctr. (IQPC), San Diego, CA

June 25, 2002

“Developing an effective CAPA system” – Seminar Speaker

Created a workshop on the subject of developing, implementing, and maintaining a Corrective and Preventive Action (CAPA). Power Point format at http://qeval.homestead.com/resume.html

Pharmaceutical Training Inst. (PTI), NYC, NY

Nov – Dec 2001

“Auditing the QC Microbiology Lab” – Seminar Speaker

Created a course for PTI based on agenda. Power Point presentations: http://qeval.homestead.com/resume.html

AssurX & Boston Scientific | Target, Fremont

March 2001 – August 01

Validation Engineer

Provided professional guidance on 21CFR Part 11 requirements and software validation needs. Audited existing procedures and developed software validation. Client contact: Sal Lucido

MBI / UroCor through Perigon / PTS, Oklahoma City, OK

June 2000 – July 2000

Quality Assurance / Validation Specialist

Supported all Quality Assurance and Validation functions. Wrote, SOP's for quality assurance, maintenance, calibration, and use of equipment. Client contact: Stanley Mills PhD, Jacqueline Mills, Tarance Grisso, David Caravaglio

Oread Pharmaceuticals through QST / Oxford, Palo Alto, CA

Feb 2000 – June 2000

Quality Assurance / Validation Specialist

Supported all Quality Assurance and Validation functions for contract manufacturer. Supported technology transfer. Performed cleaning validations and equipment validations. Client contact: Beth Rice, Marji Prows, Tony Brown, Ken Miles PhD, Arlene Blakes.

Permanent Positions from March 1996 until January 2000 for following Employers:

Qualisys Diagnostics, Inc. Irvine / Carlsbad, CA

November 1998 – January 2000

Quality Engineer / Product Support Lead / IT Support Specialist

Validated lab and manufacturing equipment, test methods, facility, and manufacturing processes. Oversaw V&V and design transfer. Technical training and assistance. Supplier and vendor audits. Material Review Board, Quarantine and Approval process. Purchasing (over $750K), receiving, and inspections. Control of material via Material Resource Planning (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. Management: Grace Kwan, Glenn Walker, Gary Alvey.

B. Braun | McGaw, (Validations / QE Dept.), Irvine

April 1997 - July 1998

Quality Engineer Associate II

Validated / requalified equipment, new or revised products, systems, PLC's, and facilities. Investigated returned product complaints. Technical training and assistance. Performed plant shutdown operations. Management: Nannette Monreal & John Smith / previously Blair Smith

Allergan (QC dept.) (through Lab Support), Irvine

December 1996 – April 1997

Environmental Monitoring / Microbiology / Chemistry Technician

Performed environmental monitoring testing. Performed chemical and microbiological (endotoxin and bioburden) testing on medical devices. Generated 209E government req. forms and trending. Management: Rod Patterson

McGaw (QC dept.) (through Lab Support), Irvine

March 1996 - April 1997

Environmental Monitoring Technician / Media and Sterility Technician

Performed environmental monitoring. Assisted in sterility testing of final product. Led investigations and performed trending. Performed microbiological tests. Management: Myron Civils & Wendy Ricapito

ASSOCIATION MEMBERSHIP :

American Society for Quality (ASQ) from 1998

American Society for Testing and Materials (ASTM) from 1999

American Chemical Society (ACS) from 1999

International Society of Pharmaceutical Engineers (ISPE) from 2000

American Society for Microbiology (ASM) from 2002

College of American Pathologists (CAP) from 2001