JUDY BUCKHAM

acbier@r.postjobfree.com 206-***-****

http://www.linkedin.com/in/jbuckham/

Creative, outgoing, detail-oriented professional, valued for my unique

combination of technical expertise, interpersonal skills, and enthusiasm.

Self-motivated, dedicated individual and energetic team member with

excellent oral and written communication skills. Able to adapt to constant

change and to manage multiple priorities. Experience in medical devices and

biotech in both quality and regulatory affairs.

FDA Submissions ? Regulatory Compliance ? Complaint Investigation ? Medical

Device Manufacturing

Technical Writing and Communications ? Auditing ? Records and Document

Management

Problem Solving and Corrective Action ? Project Management ? Process

Quality Improvement

Clinical Trials ? Clinical Trial Monitoring ? Education and Training

EDUCATION

M.S. Biomedical Regulatory Affairs, University of Washington 2012

Bioengineering Master's Program, University of Washington 1984-1987

B.S. Chemistry, Minor in Mathematics, Idaho State University 1979

PROFESSIONAL EXPERIENCE

Seattle Biomedical Research Institute, Seattle, WA

Regulatory Affairs Associate September 2011 to November 2012

Provided support to Regulatory and Clinical Affairs Manager for phase I

Malaria Clinical Trials. Partnered with outside consultants and cross

departmental teams to develop regulatory submissions. Assisted in

implementing regulatory strategies and development plans. Prepared and

submitted regulatory documentation to required agencies and researched

information on regulatory items for external or internal inquiries.

. Compiled, formalized and submitted Investigational New Drug (IND) and

Master File updates and amendments, responses to inquiries, annual

reports, and Clinical Study Reports (CSRs) to the FDA

. Created IND and Master File annual reports

. Edited CSRs and drafted outlines for a new IND and Master File

. Created and amended regulatory and clinical procedures

. Registered and updated clinical trial information on

ClinicalTrials.gov website

. Assembled, organized and audited Clinical Trial Master Files (CTMFs)

to ensure compliance

. Organized and updated regulatory submission files, and created

complete set of electronic files

. Generated regulatory submission index spreadsheets for each clinical

trial

. Monitored Case Report Forms (CRFs) for phase I Malaria Clinical Trial.

Ensured information was transcribed correctly across all documents;

subject consent, medical history, adverse event reports, lab test

requests, lab test results, malaria evaluation, patient diaries, and

CRFs. Arranged for the revision of information which was incorrectly

recorded.

Physio Control Inc, Redmond, WA, Practicum Site

Graduate Student, Master's Program in Biomedical Regulatory Affairs 2011 -

2012

Redesigned two in-house clinical study protocols to make them more

flexible, easier to understand, and easier to use. Also revised were

consent forms and data entry sheets. Protocols were used for validation of

the LIFEPAK Defibrillator/Monitor units and accessories. Practicum title:

"Redesign of In-House Defibrillator/Monitor Clinical Study Protocols for

Shock Advisory Algorithm Testing and Characterization of ECG Quality."

Quinton Instrument Company

Quality Engineer, Medical Products Division 1987 - 1992

Worked individually and as a cross-departmental team member to create

documentation and dependable products, and to resolve problems of product

design, instruction, specification, materials, tooling and manufacturing.

Responsible for in-house quality improvement program, and medical product

quality from new product design through manufacturing, labeling, marketing,

sales, and distribution.

. Reviewed and approved manufacturing process procedures, product and

component drawings, engineering change orders, and instructions for

use by medical professionals

. Received product complaints from customers across the United States,

conducted investigations and recommended corrective action to prevent

recurrence

. Designed and implemented standard operating procedures for testing and

inspecting products and production equipment

. Initiated and facilitated Quinton Quality Action Team to address

company-wide procedural, product, or process deficiencies

. Conducted internal quality and safety audits to ensure compliance with

GMP regulations

. Guided and accompanied FDA during regulatory and compliance audits

. Designed and implemented quality management system training to all new

employees

Exxon Nuclear Idaho Company, Idaho National Engineering Laboratory

Quality Control Chemist 1981 - 1983

Supported 24 hour analytical lab to confirm accuracy of analyses. Held

high security "Q-Clearance."

. Prepared high precision standards for all plant chemical analyses

. Performed computerized statistical analyses as a method of trouble-

shooting malfunctioning experiments and for assessing the accuracy of

analytical methods and lab techniques

PROJECT MANAGEMENT AND LEADERSHIP EXPERIENCE

Garfield Spring Waltz Co-chair, Garfield High School Orchestra Parent Board

2006 - 2009

Organized spring waltz, a function attended by more than 400 people,

yearly. Organized all advertising, pre-dance lessons, decorations,

refreshments, dessert bake sale, set up, clean up, and location logistics.

Treasurer, Salmon Bay Middle School PTSA 2001 - 2004

Collaborated with PTSA board to prepare the annual budget and to determine

allocation of grants for special school projects and teachers. Prepared

monthly and year-end financial documents, reported financial status at

monthly PTSA board meetings. Received, tracked and dispersed PTSA funds

(about $200,000 each year for 350 students) and paid all financial

obligations of the PTSA. Worked with 21 teachers and 17 staff to assure

grant money was spent appropriately.

Auction Chair, Salmon Bay Elementary School 1999 - 2000

Coordinated site location, donation procurement and receiving, advertising,

decorations, food/bar, catalog, auctioneer, registration and cashiering.

Designed the system for handling incoming donations, and for creating

requested gift certificates, catalog description and thank you letters.

Directed eight committee chairs and supervised more than 25 volunteers.

Increased receipts by more than 30% each year.

Raffle Chair, Salmon Bay Elementary School 2000

Created a raffle to enhance proceeds of the school auction. Raffle proceeds

exceeded $7300. Established raffle guidelines for school raffle sales,

developed a tracking system for accountability of ticket sales, and

supervised sales and accountability of nine room representatives.

President, Interlake Childcare Parent Group 1992 - 1993

OTHER EXPERIENCE

Barista, Starbucks Coffee Company, Seattle, WA 2005 - 2011

Enhanced the Starbucks Experience for customers by providing legendary

customer service with quality beverages and products. Coached new partners

to create quality beverages and to use the cash register screens

efficiently. Valued for providing excellent customer service, workplace

enthusiasm, and for creating a fun, comfortable and friendly atmosphere for

customers and partners. Known for creating a sense of calm during stressful

times.

Science Teacher, Salmon Bay Elementary School academic year 1999 -

2000

Taught electronic circuits and food chemistry science units to

approximately 60 fourth and fifth graders in small group sessions,

utilizing Seattle School District science kits.

Classroom Volunteer, Salmon Bay Elementary School, 4 to 15 hours a week

1995 - 2002

SKILLS AND TRAINING

Human Subjects Research Training, Collaborative Institutional Training

Initiative (CITI) 2012

Computer Skills: Excel, Word, Outlook, Visio, Publisher, SharePoint, Adobe

Professional, Adobe Acrobat, Power Point, Skype

AWARDS AND SPECIAL PROJECTS

. Received prestigious "Steward of the Community" Award, May 2004 in

appreciation for outstanding volunteer work at Salmon Bay School.

. Received "Award for Outstanding Achievement in Bioengineering" from

the Society of Women Engineers, January 1985.

. Founded "Profit Prophets Investment Club," 1997. Club placed first in

portfolio contest in 2003 and third in 2002 out of more than 2000

Puget Sound clubs. Initiated Partnership Agreement and Bylaws.

Treasurer and mentor 1997 to 2009. Responsible for monthly financial

statements, year-end taxes, and member education.

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