Quality Assurance Training

Kathy Orsted, MS, CAPM, LATG

**** ******** **** ***

Portage, MI

269-***-**** (Home)

269-***-**** (Mobile)

Career Profile

Study Director/Coordinator with 6 years Nonclinical Drug Safety Evaluation

and 8 year's experience in contract research organization as Project

Leader, Study Coordinator and Senior Proposal Coordinator. Knowledgable in

ICH guidelines and toxicology study design for small molecules and

biologics. Study Director for Non-GLP studies and coauthored GLP reports

including analyzing, interpreting data and within timelines. Proficient in

test article administration, specimen collection, data collection and

necropsy for multiple species. Self-motivated to pursue continuing

education, enjoys collaboration with scientific experts, and readily adapts

to changing priorities.

Education and certifications

1998: University of Wyoming, Laramie, Wyoming

Master of Science in Pathobiology

Advisor: Dr. Merl Raisbeck

Thesis title: Mechanisms of Selenium-induced Teratogenesis: Oxidative

stress

1996: Ball State University, Muncie, Indiana

Bachelor of Science in Microbiology

2012: Certified Associate in Project Management

2009: RLATG

Professional Experience

MPI Research, Mattawan, Michigan

February 2006 - Present

scientific and sales liaison/senior proposal coordinator - Sales and

Marketing, March 2010 - Present

* Assisted Business Development Directors with triaging >4,0000

requests for proposals and requests for information for General

Toxicology, Safety Pharmacology, Pharmacokinetics, and

Analytical/Bioanalytical product lines and generated >$17,000,000

in Sales

* Liaise with Sales and Product Line Leaders to customize

scientifically accurate and cost effective study designs for

pharmaceutical, biotechnology, and chemical clients

* Developed and nurtured effective relationships with clients,

colleagues, Product Line Leaders and Operations staff

* Awarded the Team Work Award

Study Coordinator - General Toxicology, August 2009 - March 2010

* Assisted 10 Study Directors with business development, scheduling

Sponsor visits, protocol generation, pre-IACUC protocol review, and

responding to Quality Assurance audits

* Processed requests for proposals for small and large molecules, and

maintained client information in electronic database

* Generated 81 high quality proposals and 151 protocol & amendments

for various compounds

* Contributed to 130 quality assurance data/report audits and

completed 59 data requests, all within deadline.

Project Leader - Small Animal Toxicology, February 2006 - August 2009

* Supervised a high functioning technical staff of Research

Associates and implemented in-life phase of toxicology studies

phase of > 50 no clinical toxicology studies ranging from acute to

carcinogenicity studies with various routes of administration

* Generated data capture forms, study-specific procedures, and

reviewed draft protocols and study data for compliance with SOPs,

GLPs and protocols

* Directed daily tasks and generated daily work schedules for

technicians and performed in-life functions (test material

administration, clinical sampling, clinical observations) as needed

* Coordinated in-life functions with clinical pathology, necropsy,

test material control, and quality assurance to produce

GLP/SOP/protocol-complaint in-life data collection

* Established effective relationships with study directors, test

material control, sponsors, quality control, and quality assurance.

* Active participant at weekly/monthly management meetings.

Represented Small Animal operation department on Safety Committee,

Dosing Procedure and SOP reviewer

Pfizer, Kalamazoo, Michigan

August 1999 - August 2005

Research Biologist 3/ Study Coordinator -Toxicology

* Coauthored GLP and Non-GLP preclinical reports including analyzing,

interpreting data, generating technical reports and common

technical documents and common technical documents within timelines

* Study Director for non-GLP studies in rodents and rabbits

* Proficient in skills in various techniques for toxicity evaluation

including test article administration, specimen collection, data

collection, and necropsy for multiple species

* Adapted a new technique for the novel therapeutic area

* Laboratory research comprised bone marrow cell culture, HPLC

method development and immunohistochemistry screening to determine

immunomodulatory impacts of drug candidates

* Awarded the Certificate of Appreciation from Kalamazoo Site Head

for Commitment to Performance of a Level of Excellence Consistent

with Worldwide Safety Sciences Vision

*

TriHydro, Laramie, Wyoming

1999

Risk Assessment

* Assisted geologists on test visits

* Entered data into computer database and reviewed reports for

compliance with EPA guidelines

Wyoming Game and Fish

August 1998- June 1999

DNA and Forensic Technician

* Identified species using immunoelectrophoresis and ran PCR for

gender identification and specimen exclusion

* Sectioned teeth for age analysis and population dynamics

* Assisted training wildlife personnel on specimen collection

Professional Memberships

American Association for Laboratory Animal Science

Society of Toxicology

Women in Toxicology

Project Management Institute

Professional development

Interpersonal Development

* Providing Constructive Feedback (2013)

* Helping Your Team Work (2013)

* Conflict Resolution Skills for Women (2011)

* Performance Reviews (2009)

* Clarifying Performance Expectations (2009)

* Correcting Performance Problems (2009)

* HR Managerial Training - Policies, Employee Relations, & Affirmative

Action, 2008Speaking to Influence Others (2009)

* HR Managerial Training - Compensation, PMP & Legal Compliances

(2008)

* Principles and Qualities of Genuine Leadership (2009)

* Defusing Emotionally Charged Situations (2007)

* Positive Responses to Change (2007)

* Creating a Culture of Inclusion (2004)

* Dale Carnegie (2003)

Continuing Education

* Nanotherapeutics and Diagnostics, Wyss Institute, (2013)

* Mind, Music and Medicine, Western Michigan University (2013)

* Financial Accounting (2013 - present, on-line course)

* Society of Toxicology Annual meeting (2011)

* Immunohistochemistry Validation: A Practical Discussion presented

by Leica Microsystems (2012)

* 23 hours Project Management (2010)

* The Regulations and Requirements: A Primer for Technicians (2008)

* Building Sustainability and Reducing Your Facilities Carbon

Footprint (2008)

* Diversity: Issues in Lab Animal Science (2008)

* Improving Operational Efficiency in Animal Resource Management Using

Lean Thinking (2008)

* Rodent Microbial Surveillance: Recommendations, Practices,

Rationales and Perspectives from Different Programs and Parts of the

World (2008)

* Environmental Monitoring and Containment Control Technologies for

Comparative Medicine Facilities (2008)

* Animal Models of Substance Abuse and Addictions (2008)

* Searching for a Cure of Fatal Neurodegenerative Diseases (2008)

* Behavior Testing in Rodents (2008)

* Standard Operating Procedure Author Training (2007)

* Pharmaceutical Sciences Workshop (2005)

* 3D Drug Discovery and Development (2005)

* Handling Sensitive Information (2005)

* Mid-America Toxicology Course (2004)

* Systematic HPLC Method Development Using DryLab (2000)

* Practical HPLC Troubleshooting (2000)

* Advanced HPLC Method Development (2000)

GLP/OECD Training

* Refresher GLP Training - FDA Inspector Refresher and AAALAC Training

(2005)

* Refresher GLP Training (2004, 2012, 2014)

* GLP Additional Training: GLP for Technical Staff, Study Directors

and Monitors presented by Deb Garvin (2004)

* Electronic Signature of Safety Sciences Protocols and Study Reports

(2004)

* Use and Maintenance of Laboratory Notebooks (2004)

* Information Protection Program Training (2004)

* Part 11 Electronic Records: Electronic Signatures (2004)

* GLP Additional Training - Inspection Readiness (2004)

* Accountability for Electronic Signatures (2003)

* GLP Additional Training: Study Director Training (2003)

* GLP Multi Site Studies (2003)

* Multi-site training (2003)

* 21 CFR Part 11 (2002, 2006,)

* GLP Continuing Education Seminar (2002)

* OECD GLP (2002)

* Xybion Path/Tox System Protocol Entry T:Module Scheduling (2001)

* Xybion Path/Tox System: Extended Clinical signs (1999)

* Raw Data (1999)

Publications

Orsted KM, Dubay SA, Raisbeck MF, Siemion RS, Sanchez DA, and Williams ES.

1998. Lack of Relay Toxicity in Ferret Hybrids fed Carbaryl-treated prairie

dogs. Journal of Wildlife Diseases. 34:3622-364

Mitchell, James K., Maleki, Saber, Orsted, Kathy M., Rawlings, Richard J.,

and Price, Catherine. 1997, Fun Microbiology: How to Measure the Growth

of a Fungus. The American Biology Teacher. Vol. 59, No 4:220-223.

Mitchell, James K, Orsted, Kathy M., and Warnes, Carl E. Nov. - Dec. 1997.

Fun Microbiology: Using a Plant Pathogenic Fungus to Demonstrate Koch's

Postulates. The American Biology Teacher, Vol. 59, No. 9:574-577

presentations

Platform

Interactions influencing selenium toxicity in aquatic species on reclaimed

mine lands. 1997. Abandoned Coal Mine Land Research Project, 9th Project

Review Seminar, Gillette, WY

Mechanisms of selenium-induced teratogenesis: oxidative stress. 1998.

Rocky Mountain Society of Environmental Toxicology and Chemistry, Fort

Collins, CO

Poster

Orsted KM, Raisbeck MF, Sanchez DA, and Siemion RS. 2001. Mechanisms of

selenium-induced teratogenesis and embryolethality. Society of Toxicology

40th Annual Meeting, San Francisco, CA

Orsted KM, VanderEide SA, Johnson CW, Zhao S, and Rudmann DG. 1999.

Immunophenotyping as a methodology for evaluation of immunomodulatory

effects of drug candidates. Pharmacia & Upjohn Biology and Biochemistry

Research Symposium, Kalamazoo, MI

Contact this candidate