Manager Quality

Max Scates, ms, CPGP, CBM, lssbb

**** ******'s Way 615-***-****

Gallatin, TN 37066 ********@*******.***

Qualification Summary

A senior manufacturing professional with over 20 years experience in

operations production and quality. Strong leadership and problem solving

skills with a focus on building collaborative teams and individual

empowerment. Strategic thinker and planner balancing corporate margins,

revenue streams, quality processes and people development. Lean manager

emphasizing cross-training for maximum production efficiency and financial

stability. Strengths include:

Operations Management Cross-functional Team Leadership

Customer Interaction Vendor Selection/Management

Identifying Cost Reductions Identifying Business Opportunities

ISO 9001 Management Mentoring

Professional Experience

Cardinal Health, Specialty Pharmaceutical Services, La Vergne, TN 2008 to

present

Quality Assurance Audit Manager

Directs quality audit function which conducts cGMP internal audits, hosts

client and prospective client cGMP audits, hosts corporate quality and

regulatory affairs audits, and corporate global trade audits.

. Earned American Society for Quality Pharmaceutical GMP Professional

certification.

. Developed internal audit questionnaires containing over 700 questions

that address our applicable requirements of 21 CFR, DEA, FDA, and DOT.

Developed an internal audit schedule and ensured all audits were

conducted on schedule.

. Developed a business overview used during client and prospective client

audits to familiarize auditors with our overall business operations and

services offered.

. Assisted our sales team by developing a brochure that briefly describes

our warehouse operations and quality management system procedures and is

provided to prospective clients.

. Schedules, hosts and provides excellent audit support to 74 clients

including ensuring 100% of all client audit replies are completed with 30

days of receipt. Clients include Baxter, Cephalon, Novartis, Daiichi

Sankyo, Amylin, Millennium, Takeda, Talecris, ZymoGenetics, Azur,

Lundbeck, and UCB.

. Developed an ISO 13485 (ISO 9001:2008 based) quality manual and SOP for

management review.

. Received a client voice of the customer survey score of 100% for audit

support, 71 clients were surveyed by the account management team.

. Serves on Lean Six Sigma Black Belt projects providing manufacturing and

inventory experience.

. Identified the need for and helped implement a Strengths, Weakness,

Opportunities, and Threats process.

. Conducts trend analysis by reviewing internal and external audit findings

looking for systemic issues, ranks them on a Pareto chart, and works with

managers to develop corrective action plans as needed.

. Received no audit findings during the 2010 four days corporate quality

and regulatory assurance audit. This is a major improvement over the 2007

audit that resulted in 13 medium risk findings prior to my joining the

company.

Completed Lean Six sigma black belt training with GE Medical Systems

2007

Master Black Belt

Max Scates

Page 2

Illinois Tool Works, California Industrial Products, Gallatin, TN 1999-

2006

Automotive Fastener Stamping Division

Quality Manager

Directed product quality and customer satisfaction operation, and quality

engineering team, production auditors, and laboratory technicians. Managed

and allocated $1.6M annual budget.

. Displayed initiative by determining the feasibility of machine sorting

parts. Analyzed computer sort data and formed a cross-functional team

charged with reducing product sort costs. Determined the capital

procurement needed to install error-proofing sensors and camera vision

sort systems that consistently and accurately identified parts "out of

specification"; reduced monthly costs from $221K to $37K. The $2.2M

savings achieved went directly to company's bottom line and gave the

company a competitive advantage over its rival.

. Conducted supplier audits to ensure they had an effective quality system

and product met manufacturing requirements. Issued findings and tracked

CAPAs to determine their effectiveness.

. Integral member of team developing and maintaining TS 16949, ISO 14001,

and ISO 17025 quality systems. Developed policies, procedures, and work

instructions for the plant. Worked directly with auditors and management

of quality system registrars NSF and LAB. Led the internal audit team.

. Helped train and lead the efforts in the implementation of Lean

Manufacturing and 5S. Ensured the elimination of "Muda" during lean

manufacturing process flow reviews with cross-functional teams. Conducted

5S and TPM audits to verify the effectiveness of the programs.

. Worked closely with production and materials management to ensure

customer on-time delivery requirements were met. Reviewed MRP data to

determine material deficiencies and worked with suppliers to determine

delivery obstacles and implement permanent corrective actions. Maintained

a Nissan delivery rating of 100%, DaimlerChrysler "Drive" score of 96%,

and GM 100%.

. Assisted the safety committee in the implementation of new safety ideas

and ensured all employees wore personnel protective equipment as

required. In fifteen months we improved our safety rating from "Worst" to

"Best" among ITW stamping facilities worldwide.

. Promoted employee relations by utilizing an "open door" policy to improve

employee communication, resolve conflict, improve morale, and meet long

term management objectives.

. Increased OEE by improving the TPM program. Led a cross-functional team

that determined appropriate equipment PM cycles and mean-time-between

failure for perishable tooling.

. Using analytical skills and computer data, led cross-functional

continuous improvement teams using problem solving tools 8D, 5Whys, Plan,

Do, Check, and Act, Ishikawa diagrams, and process flow charts. Reduced

rejected product pieces-per-million (PPM) to zero for DaimlerChrysler,

Nissan, and General Motors. Total plant rejected PPM was 16, well below

industry standard of 50.

. Developed and reviewed key process indicators for production, scrap, OEE,

first-time-through, the cost of quality, PPM, customer satisfaction, and

delivery ratings to identify opportunities for improvement and assisted

production teams implement plans of action.

. Took the initiative to analyze unsuccessful sales attempts to with Nissan

Trading Company. Utilized consultative sales techniques, identified

obstacles, developed approach plan and resolved an assembly line

application issue. Booked sale in first attempt; led to revenue flow of

$257K today.

Transmission Technologies Corporation, (Spicer Transmission), Knoxville, TN

1998-1999

Engineering and Quality Manager

Directed incoming materials and final product inspections. Implemented QS

9000 and led new product design. Led four quality technicians, two design

and two manufacturing engineers.

. Spearheaded the quality system conversion from ISO 9001 to QS 9000.

Directed cross-functional teams in the development of a QS 9000 quality

manual, procedures and work instructions.

. Led cross-functional teams that improved quality rating from 82 to 96 in

less than 12 months.

Max Scates

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Professional Experience (Continued)

United States Navy 1992-1996

Weapons Test Squadron, Naval Air Station, Point Mugu, CA, 1993-1996

Manager of Production, 1994-1996

Led the manufacture and repair of aeronautical components in support of

seven customer activities. Planned, managed, directed, and controlled the

production control efforts of 191 military, 32 civilian, and 11 contractor

personnel. On average scheduled the manufacture and repair of 2,208 total

items monthly valued at $33M. Prepared, allocated, and managed $7M annual

operating budget ensuring the support needs of seven departments were met.

. Showed initiative by developing a Maintenance Training Improvement

Program (MTIP) to assess personnel skills levels and provide "just-in-

time" training to meet operational needs. Both individual's skills levels

and the operational readiness of seven squadrons significantly increased.

. Utilized TQM team principals and Isikawa charts to identify and develop

improved business practices. Improved production effectiveness 17%, and

reduced production backlog 14%.

Department Head of Aircraft Targets Maintenance and Material Control, 1993-

1994

Directed the production of 32 civilian and three military personnel

maintaining 14 QF-4N aircraft.

. Utilized and leveraged research, MTIP, and TQM principles and techniques

that improved aircraft availability 19% and electronic systems 12%.

. Analyzed processes and programs that identified an unnecessary aircraft

maintenance engine procedure ultimately saving $32K per engine and $992K

aircraft maintenance program costs.

Intermediate Maintenance Activity, Naval Air Station, Miramar, CA, 1992-

1993

Production Manager of Avionics, 1992-1993

Led the manufacture and repair of aeronautical components in support of 28

customer activities.

Directed 16 personnel, and inspired and motivated 501 military and 34

civilian personnel to achieve record levels of production.

. Utilizing TQM principals and management information system data, planned,

organized, and allocated the department resources that achieved an

unprecedented inventory production backlog of zero. Had never been

accomplished before and became the norm.

. Coordinated maintenance training and material resource efforts that

improved aircraft radar availability 21%. Identified training needs,

acquired training, and expedited replacement components.

Education/Training/Certifications

M.S. Operations Management, University of Arkansas, Fayetteville, AR

B.S. Business Management, La Verne College, La Verne, CA

Certified Pharmaceutical GMP Professional - American Society for Quality

Certified Business Manager - Association of Professionals in Business

Management (APBM)

Certificate in Human Resources - American Management Association

Special Expertise: Lean Six Sigma Black Belt trained by G. E. Medical

Systems Master Black Belt. Completed the following training: Advanced

Project Management at UC Santa Barbara, APICS Basics of Supply Chain

Management at Nashville State, Managerial Grid at Dana University, and

Kaizen Facilitator and Lean courses with the University of Tennessee.

Proficient in Microsoft Office applications and have completed Excel

intermediate and advanced courses.

Professional Affiliations

Member of Association of Professionals in Business Management (APBM), APICS

(formerly known as the American Production and Inventory Control Society),

American Society for Quality (ASQ), and International Society for

Pharmaceutical Engineering (ISPE).

Contact this candidate