Quality Assurance

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

Overland Park, KS ***** Cell 913-***-****

E-mail: *********@*****.***

Resume of Katherine L. Brown, CSSBB

Objective

My objective is to become an integral part of the Quality and/or Regulatory department. I believe

that I could be a great asset to your company. My skillset includes:

- I am able to adapt to my work environment quickly

-Management and supervisory training

- Certified Six Sigma Black Belt

- I am extremely computer literate, MSOffice suite, Prezi, several types of budgeting software.

-Annual budgeting and strategic planning.

-I have extensive experience with GC, GCMS, HPLC, FTIR, AAS, and ICP along with several

aspects of wet chemistry.

-The last 15 years I have been managing or directing quality control/assurance departments in the

following industries:

chemical

plastics pharmaceutical container manufacturing

medical device

clinical and non-clinical research laboratories

-Audit skills in the following regulations:

21 CFR Part 11 (electronic records)

current Good Manufacturing Practices (cGMP)

Good Laboratory Practices (GLP)

Good Clinical Practices (GCP), College of American Pathologists (CAP)

Clinical Laboratory Improvement Amendments (CLIA)

Health Insurance Portability and Accountability Act (HIPAA)

ISO-9001:2008

-Writing and implementation of Standard Operating Procedures, Protocols and Validation Plans.

-Internal and external auditing quality systems

Education in Chemistry and Mathematics

06/1981-08/1984 Pittsburg State University Pittsburg, KS

09/1984-12/1985 Arizona State University Tempe, AZ

Professional experience

9/2013-2/2015

American Heart Association/American Stroke Association

Director, Quality and Systems Improvement KC metro, Kansas and Nebraska

As the Director of Quality and Systems Improvement, I worked with hospital systems within the

KC metro and the states of KS and NE to improve cardiac and stroke care through quality

improvement initiatives. I work extensively with hospital co-ordinators in order to ensure the best

evidence based care is available at their facility and through their system of care. I also work

closely with EMS to ensure transportation protocols are administered using the best evidence-

based methods and root cause analysis to improve limitations in the system of pre-hospital care.

10/2009-8/2013

Heartland Kidney Network (End Stage Renal Disease Network 12)-Federal Contractor for

CMS

Director, Quality Improvement

The Quality Improvement Director directed, coordinated, developed, implemented, and evaluated

the quality improvement program and associated initiatives for dialysis and transplant facilities in a

four-state region (IA, KS, MO, NE).

I was responsible for writing and producing data charts for technical papers presented to CMS. I

am responsible for oversight of patient complaints and grievances. I presented at regional and

national conferences on general quality improvement and specific workshops for dialysis facilities.

I currently sit on the state of Kansas HAI Advisory Board as a technical expert. I directed

coordination of care quality improvement activities as well as work with facilities and patients on

including patients in their quality of care activities. I was responsible for development of

interventions and educational materials used to improve patient outcomes at dialysis facilities as

required by CMS core measures. I worked with State Survey agencies to determine facilities that

require specific quality training workshops and presented these workshops over the network at a

minimum of 10 times per year. I have worked with each of the four QIOs within our Network on

mutually beneficial projects.

2/2009-10/2009

Dadson Manufacturing Corporation/Epic Medical Concepts and Innovations (Privately

owned Medical Device Manufacturer and Research group) Grain Valley, MO

Director of QA/QC and Regulatory Affairs

I was the Director of QA/QC and Regulatory Affairs for a small Medical Device manufacturer. My

duties included but were not limited to maintaining the ISO 13485 and ISO 9001 registrations and

FDA compliant quality management system. I promoted the culture of teamwork within the

manufacturing and research departments. I was responsible for Quality Assurance Audits. I was

responsible for maintaining the Corrective and Preventive Action program, the internal and

external audit programs. I was responsible for raw material release, in-process testing and final

product release of medical devices. I reported directly to the President of the company. I held

monthly quality meetings with the quality group and the manufacturing group to go over new

procedures, complaints, general training issues, etc. I maintained all field experience reports for

our medical devices. I was working on a PMA for a new device launch in 2010.

3/2008-2/2009

EntraCare/Nexus Medical, LLC (Privately owned Medical Device Manufacturer and research

group). Lenexa, KS

Director of QA/QC and Regulatory Affairs

I was the Director of QA/QC and Regulatory Affairs for a small Medical Device manufacturer. My

duties included but were not limited to maintaining the ISO 13485 registration and FDA compliant

quality management system. I promoted the culture of teamwork within the manufacturing and

research departments. I was responsible for Quality Assurance Audits. I was responsible for

maintaining the Corrective and Preventive Action program, the internal and external audit

programs. I was responsible for raw material release, in-process testing and final product release

of Class II medical devices. I managed a department of four personnel, with three on day shift

and one on second shift. I reported directly to the owner and President of the company. I held

monthly quality meetings with the quality group and the manufacturing groups to go over new

procedures, complaints, general training issues, etc. I maintained all field experience reports for

our medical devices and was working with our distributor to obtain CE marking for all of our

product lines.

2/2004-3/2008

Alphapointe Association for the Blind (non-profit) Kansas City, MO

Director, Quality Systems (promoted from previous position)

I was promoted to Director, Quality Systems on September 19, 2006 in recognition of obtaining

ISO 9001:2000 registration for Alphapointe Association for the Blind. I was previously in the

position of Manager of Quality Systems. I established and maintained a Quality Management

System where none had existed before. I established the culture of teamwork between

departments

and it was working on the manufacturing end of the building. I was responsible

for the Quality Assurance Audits as well as the Quality Control Laboratory. I

implemented a young but robust QMS that obtained ISO 9001:2000

registration by BVQi in under two years. I was responsible for all Corrective

and Preventive action clearances. I was responsible for raw material release,

in-process testing, and final product release of pharmaceutical containers and

writing instruments for government contracts with the GSA, DOD and VA. I

managed a department of five personnel, with three on day shift, one on second

shift and one on third shift. I participated in strategic planning and

budgeting for Alphapointe. I sat on our senior management team and

report directly to our President and CEO. I instructed all manufacturing

employees in procedural instructions and in regulatory training sessions

including cGMP and ISO 9001:2000. I have been recommended as a provisional

team lead auditor for ISO 9001:2000. I trained the internal audit team

and manage the internal and external audit programs for Alphapointe as required

by our ISO registration. Our audit team was comprised of team members from

manufacturing, quality, sales, and customer service. We completed our first surveillance audit of

our ISO Quality Management System and received zero non-conformances.

7/2002 - 10/2003

Clinical Reference Laboratory (Privately Owned Lab)

Lenexa, KS

Quality Assurance and Regulatory Affairs Manager

I established and maintained a corporate-wide Quality Assurance plan. I

coordinated and harmonized all departmental QA policies and procedures. I

oversaw the creation of inter-departmental QA activities. I introduced and

maintained SPC measurements for the entire organization. I analyzed corrective

and preventative action reports to determine the root cause. I propose quality

improvement steps. I hired, trained, motivated, and evaluated QA Auditors and

Safety Officers. I reviewed general laboratory, Information Systems, Clinical

Trials and the Warehouse for maintenance records, quality control records,

out-of-control situations, procedures, equipment maintenance, problem

situations, and security. I maintained accreditation and compliance with

relevant regulations and laws. I prepared the organization for on-site

inspections. I monitored safety training for OSHA and CLIA compliance. I

coordinated continuing education for company personnel. I assisted departments

in updating Standard Operating Procedures and archiving of relevant documents.

I implemented an electronic document control system to streamline the document

system and reduce the number of personnel hours required to maintain the

documents. I assisted departments with validation of systems, methods, and

instrumentation. I maintained a quarterly report of QA and Safety activities.

I maintained a database of external audit findings and audit responses to

sponsors. I continually brought ideas to upper management's attention to

improve productivity, service, quality, policies & procedures, cost saving and

utilization of company resources. I provided regulatory training for GLP, GCP,

21 CFR part 11 for the Clinical Trials division and the Analytical Laboratory.

I trained the entire organization regarding the implementation of HIPAA within

the company. I sat on several committees within the organization including

two strategic business unit committees and the charitable giving committee. I

was the lead facilitator for the Compliance Team and the Quality Improvement

Team within the company. I submitted an annual QA Department evaluation, a

budget and strategic plan for the upcoming year to the VP/Corporate Secretary.

11/2001 - 6/2002

Xenotech LLC (Privately Owned small research lab) Lenexa, KS

QA Auditor II

As a Quality Assurance Auditor II for a biotechnical firm that specializes

in pre-clinical drug trials. My duties included, but were not limited to:

data, laboratory and facility (both internal and external) audits for

their adherence to the Federal Drug Administration (FDA) and the

Organisation of Economic Cooperative Development (OECD) guidelines for

GLPs, Standard Operating Procedure (SOP) reviews for management approval,

and auditing for CFR part 11 compliance.

11/1998 - 8/2001

ITW Dymon (a division of Illinois Tool Works) Olathe, KS

Quality Supervisor

I was the quality assurance/control supervisor for the quality laboratory in

a chemical manufacturing plant that specializes in industrial cleaning

chemicals, chemical medical devices, and over-the-counter drugs. My duties

included, but were not limited to: adherence to GLP, cGMP, FDA, and EPA

regulations, ISO-9002, SOP writing and implementation, method development

and implementation, method revisions, data review and approval, raw

materials approval, new vendor raw materials approval, final product

certification, equipment maintenance, new equipment acquisitions, and

daily supervision of laboratory technicians and quality control

inspectors. I maintained and used the following equipment: 1-Varian GC

with FID detector, 1-Perkin Elmer FTIR and several miscellaneous wet

chemistry instruments.

11/1994 - 11/1998

Inspec USA (formerly a division of BP sold to Laporte in

Nov. 1998 now operating as a division of Degussa) Galena, KS

Analytical Chemist Supervisor Quality Control Laboratory

I was the analytical chemist supervisor for the quality control laboratory

in a chemical manufacturing plant that specializes in specialty and fine

chemicals, including pharmaceutical intermediates. My duties included, but

were not limited to: adherence to GLP, cGMP, FDA, and EPA regulations, ISO

9000, method development and implementation, method revisions, data review

and approval, raw materials approval, new vendor raw materials approval,

final product certification, equipment maintenance, new equipment

acquisitions, maintained an on-call status 24 hours per day for six days a

week on a yearly basis, internal and external quality audits, and daily

supervision of laboratory technicians. I maintained and used the following

equipment: 9-Hewlett-Packard 5890 GC's (with integrators and with

ChemStations, with TCD and FID detectors, and with manual and auto

injections), 1-Mattson 1020 FTIR, 1-Perkin-Elmer 3300 Atomic Absorption

Spectrophotometer, 1-Perkin-Elmer Plasma 400 ICP, 3-Brinkman 716 Titrino

Autotitrators, 2-Spectra Physics HPLC and several miscellaneous wet

chemistry instruments.

3/1986 - 10/1994

Quality Water Analysis Laboratory, Inc (Privately Owned

environmental laboratory no longer in business) Pittsburg, KS

Analytical Chemist/Wet Chemistry Supervisor/Organics Supervisor/Customer

Services/Quality Control Officer

I was an analytical chemist for an environmental laboratory for eight years.

I worked my way up through the company from an analyst to departmental

supervisor in first the wet chemistry department and then the organics

department. I developed the LIMS (Laboratory Information Monitoring

System) system used for our database and I was then promoted to customer

services/quality control officer. I supervised as many as five analysts

during my tenure at QWAL. My duties included but were not limited to

method development, data review, understanding and providing customer

services based on EPA guidelines including SW486, database management of

the LIMS system and internal quality control of all departments. I worked

with a large array of instrumentation including GC, GCMS, Technicons,

HPLC, FTIR, AAS, ICP and several wet chemistry applications.

Professional Accomplishments

-Created a quality management system at Alphapointe where none had existed before. The QMS

passed the first ISO 9001:2000 audit in July 2006 only 18 months after project initiation with only

three minor non-conformances which were resolved in August 2006. The QMS has passed the

surveillance audit performed July 17 and 18, 2007 with no non-conformances and has retained

certification for another year. Created internal audit teams with a cross section of competent

workers at Alphapointe to assure policies and procedures are met. Created external audit teams

with a cross section of competent workers at Alphapointe to aid in making our vendors better.

-Created and maintained the Corporate Compliance Program at Heartland Kidney Network.

Created and implemented the first corporate compliance training program within the Network.

-Worked with local ASQ section to train coaches for deployment within dialysis facilities. These

coaches are volunteers and work to mentor dialysis facilities in quality language and tools.

-I presented on Annual Facility Scorecards and Data Trending at QualityNet 2011.

-Presented on Quality Improvement 101 at Iowa Council of Nephrology Nurses and Technicians in

October 2012.

-Presented on the State of Renal Networks for CIMRO Nebraska’s Quality Forum June 2013.

-Presented on Quality Incentive Program for End Stage Renal Disease January 2013 at the

Heartland Kidney Network 25th Anniversary convention.

-Published (June 2013) Infection Control and Hospital Epidemiology “The Current State of

Validating the Accuracy of Clinical Data Reporting: Lessons To Be Learned From Quality and

Process Improvement Scientists”

-Winner of American Heart Associations’ Newcomer of the Year for 2014.

- Presented on the Use of Action Registry to promote Quality Improvement in Hospitals and EMS

in responding to ST-Elevated MycardioInfarctions at the 5th Annual KS Stroke and STEMI Summit.

Citizenship Status

Natural Born United States Citizen

Professional Certifications

Certified Six Sigma Black Belt May 2013 to present

Registered Quality Assurance Professional-Good Laboratory Practices

(RQAP-GLP) 2003-2006

Provisional Team Lead Auditor ISO 9001:2000 (RAB) 2006-2009

Professional memberships

10/2002 - Present Midwest Society of Quality Assurance

10/2002 - Present American Society of Quality

10/2002-Present Kansas City Section of ASQ (Secretary since 10/2011)

7/2009 - Present Regulatory Affairs Professional Society

Civic Activities

Animal Haven volunteer since 1999

Wayside Waifs volunteer since 2009

State of Kansas Healthcare Acquired Infection Advisory Board member

Volunteer for activities Alphapointe Association for the Blind

Learned American Sign Language (Conversational) at Johnson County Community College in

order to speak to Alphapointe's deaf/blind workforce.

Hobbies

Certified Natural wildlife habitat maintained in my yard.

Certified Monarch Way Station maintained in my yard.

Owner of Hardy St Photography (specializing in wildlife and astrophotography)

References Available upon request.

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