Quality Control Software

Donna Marie Brown

*** ******* **, *********, ** *9036 Cell: 979-***-****

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

Personal Statement:

I am honest, hardworking and enjoy learning. I am very dedicated to the goals that I pursue and I assure you

that I will be a great asset to your company.

Skills:

5+ year’s laboratory experience:

• Adhere to GMP and company policies

• Knowledge of FDA-21 CFR requirements

• Model and promote Environmental Health and Safety

• Trained in BSL-2 and BSL-3 operating and safety procedures

• Mastery of aseptic techniques

• Perform standardized scientific assays

• Compiling and analyzing data

• Problem solving and root cause analysis

Leadership:

• Key player in setting the foundation for a new company and participation in company transfer

• Preparing grant proposals and management plans

• Create, review and adapt operating procedures

• Present quality control results to quality, manufacturing and product development

departments

• Attend company meetings at all levels

• Participate in interviewing, hire and training of new staff

• Prepared budgets for both in-house and outsourced assay cost, material cost and new

equipment purchases regarding client specific projects

• Provided layout feed back to the new laboratory design team to help create the

most efficient workspace for the quality control staff.

Education:

Masters of Science 2014

Texas A&M University

Parasitology

Fisheries Management

TOC Solutions for Cleaning Validation Challenges Certificate of Completion 2013

GE Analytical Instruments lecture and discussion Seminar, Austin, TX

TATEP 2009

Center for Teaching Excellence

Successful completion of Teaching Assistant Training & Evaluation Program

Bachelor of Science 2009

Trine University (formerly Tri-State University)

Major: Biology

Minor: Chemistry

Associate in Science 2006

Kellogg Community College

Associate in Arts in Liberal Arts 2006

Kellogg Community College

Associate in General Studies 2006

Kellogg Community College

Software Experience:

• Microsoft Office 2007: Word, Excel, Access, and Power Point

• Stella ® Modeling and Simulation Software

• Arc GIS® Mapping and special analysis Software

• Bio-Rad Laboratories Image Lab Software version 4.0

• WinKQCL™ Endotoxin Detection & Analysis Software

• Sievers* 900 Autosampler and DataPro 900* + DataGuard Software

• BioTek Gen5™ Data Analysis Software

Chemistry Experience:

Successful completion of the following courses: General Chemistry I, General Chemistry II, Organic

Chemistry I, Organic Chemistry II, Quantitative Analysis, Biochemistry, and Instrumental Analysis. During

my studies I became familiar with the following techniques: Flame Atomic Absorption Spectroscopy, High

Performance Liquid Chromatography, Differential Scanning Calorimeter, Ultra-violet spectrophotometer,

Infrared Spectroscopy, Gas Chromatography and gas Chromatography-Mass Spectroscopy. Additionally, I

have over 30 hours experience using Flame Atomic Absorption from an extensive soil study which was part of

my Instrumental research.

Employment:

Quality Control Analyst Kalon Biotherapeutics, LLC

May 2012 –Sep 2013.

As a Quality Control Analysts, I was responsible for performing both routine and non-routine quantitative and

qualitative analysis of samples submitted to the Quality Control Laboratory. I was involved in nearly every

aspect of the drug manufacturing process. I performed Release testing, In-process testing, Final product

testing, Stability testing, and Environmental monitoring. Essential job functions extended far beyond my job

title as I worked for a startup company where I was among the first 20 employees hired and many positions

were not yet created or filled. With minimum staffing, we were able to pull together as a team “wearing many

hats” to create a company from the ground up. We became a full scale biotherapeutic and drug development

center with the capabilities to support all classes of biological drug products including vaccines, monoclonal

antibodies, cellular and gene therapies using full upstream and downstream processing in under a year.

Essential Functions:

• Perform and provide training on laboratory methods and instrumentation

• Research literature and develop assay methods

• Coordinate with EHS to maintain EHS requirements in new protocol development

• Adapt, develop, or follow assay protocols and summarize results

• Follow all established laboratory, regulatory, safety, and environmental procedures

• Adhere to standards of quality ruled by current GMP and company polices

• Perform routine data entry and data trend analysis

• Author, review and update SOP’s and understand how to follow complex written procedures

• Have excellent organizational, written communication and oral communication skills

• Follow good documentation policies in all phases of work; provide reports for review in a

timely manner; work with other lab personal on projects and participate in Out-of-

Specification and failure investigations; recommend possible corrective actions.

• Track inventory and supervised all ordering for Quality Control Laboratories

• Log laboratory equipment

• Responsible for tours and presentations of Quality Control Laboratory

• Attend meetings and phone conferences

• Continuation of training as new assays arise

• Participation in large scale company transfer

• Participate in both internal and external company audits

• Perform the following assays: Appearance, pH/Conductivity, UV/Vis, Agarose Gel,

Restriction Enzyme, Baterophage, DNA Sequencing, Bioburden Entotoxin, Sterility, BCA,

Total Organic Carbon

• Perform client specific testing

• Responsible for periodic surface sampling, air sampling, water sampling, along with all

microbiology laboratory testing for clean room environmental monitoring during

manufacturing fills

Graduate Student Texas A&M University

Aug 2009 – Current.

I have practiced laboratory skills, grant writing, literature searches and conducted extensive research on the

genus Podocotyle. In addition I have created a feral hog management plan for a Texas land owner.

Work History:

Habitat Restoration The Wetlands Initiative

May 2009 – July 2009

I aided in the transportation of several hundred prairie plants for the Grant Creek Restoration Project at

Midewin. During this time I was employed by the Wetlands Initiative to restore wetland resources under the

project. Job duties included planting, plant identification, sorting and determining areas where dry, mosaic

and wet plants would be most appropriate to be planted.

Pharmacy Technician CVS Pharmacy

March 2004-December 2005

Collected prescriptions and patient information, process insurance and prescriptions, counted pills, checked

out customers, answered telephones and pharmacy inventory. Aided in the training of incoming pharmacy

staff.

Pharmacy ClerkRite Aid Pharmacy

December 2002-May 2003

Collected prescriptions, counted pills ran cash register and aided customers. This position was part of a

work-study arrangement for High school.

References

Emma Carrigan Texas A&M University

Phone: 979-***-****

Ira F. Jones, Ph.D. Chemistry Professor, Science Dept. Trine University

Phone: 260-***-****

Sonja Stampfler Chemistry Professor, Kellogg Community College

Phone: 269-***-****

Karl Duda, R.Ph. CVS Pharmacy

Phone: 517-***-****

Contact this candidate