Quality Control Project Manager

Betsy Beard Holbrook

*** ******** *****, **********, **, 29605 404-***-**** abnmcl@r.postjobfree.com

Microbiology, Quality Assurance, cGMP Manufacturing

“I am pleased to write this endorsement for Betsy Holbrook. Her organizational skills and attention to detail

are excellent.

One particularly admirable quality is the ability to work independently and stick to a timetable.

I have known Betsy for over 15 years…relates well with all strata of people…

Out going personality, is interesting, has substance, and is fun to be around,”

Steven D. Budnick, D.D.S. Emory University School of Medicine.

Select Achievements:

• Master’s Degree in Microbiology, UNC Chapel Hill

• Certified Medical Technologist, American Society of Clinical Pathologists (ASCP #093923)

• Certified National Pharmaceutical Representative (CNPR® #567992009).

• Member, Writing Committee, Collaborative Islet Transplant Registry, Emmes Corporation, Rockville, MD,

2004-2009

• Member, American Society for Quality

• cGMP manufacturing and quality assurance sign off responsibilities

• Member, Clinical Islet Transplantation (CIT) Manufacturing Committee (manufacture of islet tissue for

transplant as a drug product, phase III clinical trials), sponsored by the National Institute of Health,

Unique Qualities:

Detail-oriented, organized and meticulous.

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Self-motivated, works independently without supervision.

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Capable, flexible, willing, able to multitask.

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Works well in high pressure situations.

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Trustworthy with unquestionable integrity.

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Works for personal satisfaction and the institutional good.

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Excellent technical writing skills

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EDUCATION PROFESSIONAL EXPERIENCE

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Master’s of Science (Microbiology and Immunology) – University of North Carolina, Chapel Hill, NC

Bachelor’s of Science (Medical Technology) – Bowman Gray School of Medicine and Salem College, Winston

Salem, NC

Professional Experience: I earned a B.S. in Medical Technology at Salem College and Bowman Gray

School of Medicine in Winston Salem, NC. I started my career in the microbiology lab at N.C. Memorial

Hospital (Chapel Hill) where I worked my way through graduate school, earning a M.S. in Microbiology

and Immunology. I continued microbiology at Grady and Emory Hospitals in Atlanta. At Emory Dental

School I developed complex microbiological media to diagnose and treat periodontal disease. We

offered this developing science as a service to dentist across the country for many years, until the dental

school closed. After several rewarding years in the infertility lab, my latest challenge has been in islet cell

transplantation for people who suffer from type I diabetes. We manufacture a complex drug product

under FDA oversight, and I interpret, enforce and sign off on the challenging regulatory requirements.

I have relocated to Greenville and am looking for a position in the area .

Professional Experience

August 2001 to Present Laboratory Manager, Cell and Tissue Processing Laboratory

Emory University, Atlanta, Georgia

Researched, designed and created laboratory procedures, records, equipment, reagents and media for

processing pancreata and preparing islet cells in a cGMP environment for transplant into patients with

type I diabetes under phase II and III clinical trials. Processing is regulated by the FDA with the same

criteria as drug manufacture.

Train new employees, as well as current employees when new procedures are implemented.

Create and deliver presentations for laboratory visitors and guests.

Receive pancreata from brain-dead donors on 24-7 basis; lead team of 5-6 people through the 8-10

hour processing and transplant.

Review production, quality control, preventive maintenance records for quality control signoff.

Participate actively in designing manufacturing process for Clinical Islet Transplantation Consortium,

which is conducting phase II and phase III clinical trials for islet transplantation. Consortium is sponsored

by NIH, NIAID and NIDDK.

Maintained daily work schedules, call schedules, vacation schedules, and generally organized lab

staff.

Designed to scale and acted as project manager the processing laboratory including a class 1,000

clean room, autoclave and dishwashing areas, glassware preparation areas, office space, lab testing space,

supply receipt, and storage.

Worked intensively with physicians and research nurses to design and write IND for this trial.

Wrote educational materials for potential islet transplant patients.

Screened, Informed and consented patients for islet transplant clinical trial.

May 2000 to August 2001 Laboratory Manager, Reproductive Biology Associates

Atlanta, Georgia

Implemented use of OSHA required Personal Protective Equipment.

Implemented quality control program in laboratory.

Wrote SOPs for lab procedures.

Implemented Good Laboratory Practice involving labeling media, aseptic dispensing of media, proper

storage of media, etc.

Began search for owners of hundreds of frozen sperm samples stored with inadequate identification,

enabling practice to obtain permission to discard the samples.

Designed new, larger lab space. Organized and moved the lab.

October 1998 to May 2000 Medical Technologist, Infertility Department

Emory University, Atlanta, Georgia

Performed endocrinology assays, semen analysis, prepared specimens for intrauterine inseminations.

Assisted in embryology laboratory with egg retrievals, fertilizations, implantations.

Organize lab physically, implemented labeling and quality control programs.

September 1983 to October 1998 Laboratory Manager, Periodontal Microbiology Laboratory

Emory Dental School, Atlanta, Georgia

• Developed culturing service offered to US dentists. Received specimens from patients with

periodontitis for culture and testing of microbes, assuring proper antimicrobial treatment.

• Researched newly discovered pathogens and growth media through literature review and laboratory

experimentation.

• Created brochures and forms with “new” desktop publishing. Marketed service through mail and

dental meetings.

• Designed “Autocheck” program, a sterilization quality control program offered to healthcare

professionals.

• Marketed these services at major dental meeting around the country.

Other Experience Medical Technologist

North Carolina Memorial Hospital, Chapel Hill, NC,

Grady Hospital and Emory Hospital, Atlanta, GA

Education

Master’s of Science, Microbiology and Immunology

Specialty: Clinical Microbiology

University of North Carolina, Chapel Hill, North Carolina

Bachelor’s of Science, Medical Technology

Bowman Gray School of Medicine and Salem College, Winston Salem, North Carolina

Certifications/Memberships

Member, Publications & Presentations Committee, Collaborative Islet Transplant Registry, The EMMES

Corporation, Rockville, MD, 2004 to 2008.

Member, Writing Committee, Collaborative Islet Transplant Registry, The EMMES Corporation, Rockville,

MD, 2008 to Present.

Member, Manufacturing Committee, Clinical Islet Transplantation Consortium, Sponsored by the DAIT,

NIAID, NIAID and NIH, 2004 to present.

Contact this candidate