Quality Management

JODI LYNN BOBAK

Professional Profile

Chemist with strong organizational, leadership, and communication skills. Highly motivated, and hard working with experience in program development, validations and quality control procedures in a pharmaceutical manufacturing plant. A natural talent for analyzing problems, developing and simplifying procedures, and finding innovative solutions. An integral part of any team proven to show initiative and leadership in working towards a set goal. Ability to multi-task assignments, work with minimal supervision, and has a solid track record of consistently meeting and exceeding company goals and objectives.

Employment Experience

Caraco Pharmaceutical, Detroit, MI 2005-2007

Chemist II

• Prepare, edit and review C of A’s, specification forms, methods and SOP’s

• Prepare development, protocol, and validation reports for FDA submission on new product development

• Perform QC laboratory assays on excipients, drug substances, and drug products

• Interpret data, perform calculations, determine if material complies with USP/NF specifications

• Preventative maintenance and calibrations on laboratory instrumentation

• Pharmaceutical lab experience in FTIR, GC, HPLC, LOD, TLC, TOC, pH, Particle Size, and Wet Chemistry

Baxter BioScience, Rochester, MI 2001-2003

QC Chemistry Laboratory Technician

• Performed QC laboratory assays, validations, and research & development

• Interpreted data, organized data entry, trending systems, deviation software and presentation to QA department

• Preventative maintenance, calibrations, troubleshooting and minor repairs on laboratory instrumentation

• Trained new employees in chemical handling & disposal, aseptic techniques, and bloodborne specimen handling

• Analytical lab procedures in UV/VIS, Chromatography (GLC/GC/HPLC/IC), Flame Photometry, TOC, wet chemistry, pH, and conductivity

• Organic lab experience in Absorption Spectroscopy, FTIR, Mass Spectrometry, and NMR

• Biotechnology performance in Nephelometry, Electrophoresis, Kjeldahl, PTT, TPUV, and LAL

• ELISA performance of immunoassays; Hepatitis Antigen, Hepatitis Antibody, IgG, IgA

• Pharmaceutical experience in cGMP, cGDP, SOPs, protocol preparation & validations according to 21CFR

• Pharmaceutical documentation in OOL (OOS) investigation, exception & CAPA reports

E.I. Dupont, Troy, MI 2000-2001

Laboratory Technician

• Assisted chemist in developing specific chemical formulations to meet customer requirements on automotive paint for metal and plastic surfaces

• Prepared and blended chemical constituents for paint products

• Performed chemical coatings applications and physical characteristics analysis

• Viscosity, density, adhesion, specific gravity, crushing resistance and color

Philips Environmental Services, Windsor, ON 1997-1998

R & D Laboratory Technician

• Performed routine laboratory assays to test contents in environmental waste products

• Interpreted results and compared allowable quantities to government regulations

• Atomic Absorption, Calorimetry, pH, titrations, and sample dilutions

Harrow Agricultural Research Station, Harrow, ON 1997

Laboratory Assistant

• Cross-bred various seed lots for optimal vegetation growth under specific environmental conditions

• Analyzed and enhanced quality of soil conditions for vegetation growth and insect control

• Performed routine laboratory assays to test field soil mineral content

Education

Bachelor of Science: Mortuary Science, Wayne State University, Detroit, MI 2005

Diploma of Technology: Chemical Engineering, St. Clair College, Windsor, ON 1998

Awards & Commendations

• C. Beaver Edwards Restorative Art Award from the Department of Fundamental & Applied Sciences

• 7 Semesters on the Deans list by recognition of academic achievement

• Physics academic achievement award

Specific Training Experience

• Advanced knowledge of Windows, Microsoft Office Programs (Excel, Power Point & Word) & various database, spreadsheet & word-processing software

• Laboratory safety, environmental awareness and chemical compatibility (WHMIS, EHS, OHSAS, ISO14001)

• Specific training in; 5S Lean Manufacturing, Change Management, Creative Problem Solving, and EHS Risk Assessment & Internal Auditing

Volunteer & Resident Training Work

Spaulding & Curtin Funeral Home, Ferndale, MI 2006-2007

• Arrangement conferences, visitations, and funeral ceremonies

• Prepare decedent for funeral; embalming, dressing & casketing, and hair & cosmetic applications

Jurkeiwicz & Wilk Funeral Home, Hamtramck, MI 2005

• Arrangement conferences, visitations, and funeral ceremonies

• Prepare decedent for funeral; embalming, dressing & casketing, and hair & cosmetic applications

(WAMR) Windsor Association for the Mentally Handicapped, Windsor, ON 1993

• Assisted disabled persons in elementary functions necessary for basic life maintenance

• Aided persons in developing their skills through reading, writing and social interaction

• Encouraged the less fortunate in various activities; including individualized and team oriented sports

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