Supply Chain Quality (farm to fork), Certified Six SIgma Black Belt

Mary Dionne Madison

**** * ******* .*******, ** *0643

773-***-**** . **********@******.***

B.S. Chemistry

1990

Xavier University

New Orleans, LA

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

1989

DePaul University

Chicago, Illinois

Board Certified Sanitations State of Illinois Department of

Public Health

ASQ-CSSBB (Certified Six Sigma Black Belt)

ASQ Member

SQF Level 3 & HACCP Certified

Project Management Professional (PMP) in Progress

Litigation Support Specialist (Consultant)

2013-To Date

Hoffman Law P.C.

Chicago, IL

Provide technical and legal knowledge in regards to the interpretation,

application and accuracy of rules (CFR's), regulations (FR's), policies,

best practices, standard operating procedures, and industry standards of

Federal Regulated industries, such as but not limited to: CPSC, FDA, OSHA,

USDA, and EPA, as well as, drafting written decision documents and

supporting administrative records capable of withstanding public, legal and

judicial scrutiny. Facilitates and makes recommendations on the assessments

of Risk Management and Analysis to mitigate client exposure and liability.

Ensures compliance with Litigation Support and eDiscovery best practices,

including pre-review quality assurance protocols, managed review workflows,

pre-production validations, adherence to production specifications, and

quality assurance checks for production deliverables. Cross-functional

communicator with attorneys, paralegals, clients, and other practice

support team members to maximize the usage of litigation support tools and

applications, as well as, gathering information used in the preparation of

project reports.

Quality Engineer (Consultant)

2013

Kenco

Manteno, IL

Provide Quality Engineering and compliance support for process development

and improvement initiatives to reinforce the goal of Operational Excellence

in a 3PL environment. Provide implementation and oversight of FDA (CFR's)

Food GMPs for warehousing. Effectively communicate the needs for

Regulatory Affairs to customers, site and senior management, synergized

with KMS Best Practices and Customer Quality to develop, deploy, implement,

and maintain best practices for meeting FDA regulatory requirements (FSMA),

quality engineering methodologies, systems, and practices that meet the

operating system's CI strategies. Developed, deployed, and implemented

Prerequisite Programs, Risk Management Programs and rankings, FMEA (HACCP),

Business Continuity Plans, Allergen, Sustainability, food defense, Quality

and IPM-PCO Plans, as well as, FSMS, KPI"s, key quality system processes,

process and change control. Implement and provide guidance and support for

Food Defense and Safety requirements, as well as, a reverse supply chain

with a $15M dollar frontline contribution. Strategically and effectively

plan, execute and resolve quality and risk conflicts both internally and

with external customers and supply chain partners. Schedule, train and

facilitate Internal and External audits in accordance with the ISO 22000,

9001 and19011 Standards. Interpret documents and regulations, as well as,

drafting written decision documents and supporting administrative records

capable of withstanding public, legal and judicial scrutiny. Conduct

training, elevate understanding and measure effectiveness for foundational

quality management processes and quality engineering disciplines from entry

positions to management level positions. Provide change management

guidance. Develop, deploy and assesses quality metrics for dissemination

of trends that affect service quality and customer reviews through the use

of Lean and Six Sigma tools (Kaizen, DFSS, DOE, and EOQ), statistics and

quality engineering tools. Create charters, presentations, technical and

entitlement reports for management, cross-functional teams, customers and

professional groups. Investigates and responds to customer complaints root

cause analysis, participate in the recommendation of corrective actions-

(CAPA's), RACI modeling, tracking the resolution process and effectiveness

of the response(s).

Food Safety Auditor (Consultant)

2012-2013

ASI Food Safety Consultants

St. Louis, MO

Prepare and conduct audits according to ISO 22000:2008, FMEA (HACCP a risk

management analysis and ranking tool), SQF, GFSI, GMP, current CODEX, FDA

and USDA specifications, as well as, other QM Systems. Evaluate, develop,

implement and modify client-specific quality objectives and food safety

manuals and defense plans on the farm to fork supply chain. Plan, present

and provide on-site educational presentations and explanations and

interpretations of food safety regulations and documents to clients, as

well as, drafting written decision documents and supporting administrative

records capable of withstanding public, legal and judicial scrutiny.

Implement, develop, deploy and coordinate project efforts between corporate

and technical staff; cross-departmental teams and Risk Management Programs,

as well as, CI team reviews of the audit program.

COO

2002-2012

Brown Sugar

Chicago, Illinois

Start-up of a mid-sized dine-in/carry-out bakery-restaurant, that

specializes in specialty deserts and specialty foods. Champion Continuous

Process Improvements, QMS, HACCP, Allergen, Food Safety/defense Plans,

RCA's, CAPA's, Risk analysis and Management both internally and with

external customers and supply chain partners, KPI'S, balanced scorecards

and QMS development, VSM, vendor identification, menu development, recipe

scale up, food procurement, personnel training, as well as, day-to-day

hands on involvement. Champion of Six Sigma and Lean Methodologies and Blue

Ocean Strategies that helped catapult Brown Sugar to be voted one Best

Things Eaten by Time Out Chicago Magazine's, Chicago Tribune Good Eating

Award recipient, Rib Fest, top 100 restaurants New City Magazine, featured

in Time Out Chicago Magazine places to go in Chicago, featured vendor at

Bloomingdale's Chicago, 190 North and The Churchill Downs Entertainment

Fork, Cork, & Style Chicago, amongst other notable mentions and local and

national accolades.

Director of Human Services

Feeding Program

2000-Present

St. James A.M.E. Church

Chicago, Illinois

Implemented and developed a start-up bi-weekly mobile feeding program for

homeless and indigent individuals in the Chicago area. Champion Continuous

Improvement, Prerequisite Programs, Risk Management Programs, QMS, Food

Safety/defense, CAPA's, budget development, in-kind donations, equipment

purchasing, menu development, procurement, preparation, human development,

as well as, ancillary services.

Sherwin Williams

1993-1999

Chicago, IL

ISO 9001 Quality Manager

Implementation, maintenance and modification of the quality management

systems used for third party ISO 9001 recertification, as well as, internal

quality auditing procedures. Utilization of ISO 9001 methodologies and QM

systems in the EPA compliance of VOC reduction, through product testing,

and process engineering modification, as well as, the computation,

analysis, interpretation, calculation, documentation, and summarization of

data for the submission of reports to local and federal EPA. Development

and execution of quality objectives, interfacing and conferring between

third party independent auditors, internal auditing, staff, and

departments, as well as, various Regulatory agencies for continuous product

improvement, cost reductions, increased customer satisfaction, and

regulatory compliance. Written decision documents and supporting

administrative records capable of withstanding public, legal and judicial

scrutiny The evaluation, modification, and development of testing methods

for continuous product improvement, through risk management, analysis and

ranking that reduced defects, delays and variability, as well as, the

implementation of in place process controls. Responsible for warranty

panels supporting 15$MM in sales, as well as, the Phoenix intermix valued

at 120$MM/year.

Regional Technical Chemist

Instrumental change agent in the development of the Regional Technical lab,

that addressed the Root Cause Analysis of non-conforming product and CAPA's

for (7) seven plants. Customer complaint resolutionist, within the region,

through customer interaction, mediation and mitigation of various customer

concerns, as well as, impending legal actions; while implementing

corrective measures for manufacturing and plant related issues improving

productivity and profitability, through analysis and process engineering

methodologies, as well as, the reduction of turnaround time from production

to fulfillment for a front line contribution of 35$MM. Supervised and

assisted technicians, as well as, factory workers through implementation of

problem solving measures. Instrumental change agent in Sherwin Williams

becoming ISO 9001 certified plant through implementation and development of

a synergy of quality management systems. Increased productivity and reduce

cost through Lean and Six Sigma Methodologies that reduced defects and

delays, while ensuring quality of processes and products through GMP's, as

well as, testing methodology evaluation, modification, and development for

maximum continuous product improvement. Implement, develop, and deploy

various coatings, as well as, process engineering for specialty groups

across the regions. Computation, analyzation, interpretation, calculation,

documentation and summarization of data results, for the ongoing purpose of

continuous product improvement and modification, while achieving maximum

customer satisfaction and profitability. Interpret documents and

regulations, as well as, drafting written decision documents and supporting

administrative records capable of withstanding public, legal and judicial

scrutiny. Collaborative efforts with marketing and design on numerous

projects to achieve optimal customer satisfaction, as well as, price

implementation, of various products for specialty groups with the company.

Quality Assurance Technician

Testing of raw materials, unprocessed and end processed coatings.

Conducted chemical and physical laboratory tests, as well as, product shelf

life analysis. Complied, analyzed, interpreted, calculated, documented,

and summarized test data for a variety of purposes, such as research,

product development, quality control, and establishing standards.

Xcel Laboratories

1992-1993

QC Chemist

Chicago, IL

Training of incoming QC Chemists, implementation, development, and

deployment of USP approved methods for QC group. Extensive knowledge and

implementation of GMP's for manufacturing. QC of raw materials, in-process

(conforming and non-conforming), and finished products for Health, and

Beauty Aides, and OTC Pharmaceuticals. Complied, analyzed, interpreted,

calculated, documented, and summarized test data for a variety of purposes:

product development, quality control-risk management, establishing

standards and FDA compliance.

Illinois State Psychiatric Institute

1991-1992 Clinical Laboratory Technologist

Chicago, IL

Researching and monitoring the levels of Receptor Binding in the mentally

impaired, through general, instrumental, and wet chemical analysis, to help

implement and develop preventive measures in the disorder. Submission of

interpreted, calculated and summarized results for maintaining organized

accurate, data of on-going experiments and results for future references

and publications.

City Colleges (Olive Harvey College)

1991-1993

GED Instructor

Chicago, IL

Supervised, instructed, assimilated, disseminated, and articulated

information to dysfunctional and/or special education students on a daily

basis.

Packaging Corporation of America

1990-1991

Scientist

Skokie, IL

General, instrumental (HPLC and GC), wet chemical analysis, and problem

solving, including both implementation and development of methods for

plastic packaging groups. Assist in-house consultation of safety,

hazardous waste, and other problems. Preparation of reports on

experiments, as well as, analysis of interpreted, summarized and calculated

data.

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