Quality Assurance Manager

RALPH MCKENZIE

***** ***** *****, ********, ******** 60441

Telephone: 815-***-****

Email: ***************@*****.***

EXECUTIVE SUMMARY:

Successful V.P. of Operations with 25-plus years of

experience developing and leading manufacturing

operations throughout U.S. sites. Credited with

facilitating process change and implementation through

training, direction and motivation of plant and

management teams. Adept in state-of-the-art

manufacturing technologies and processes. Highly

developed problem-solving skills with ability to deliver

innovative solutions to operating challenges. Multi-

talented with broad experience in:

> Quality & Performance Improvement

> Multi-Product Manufacturing Operations

> Technology Planning & Direction

> Budgeting, Cost Reduction & Profit Growth

> Strategic Planning Direction

> Capital Improvements & Facilities Management

> Pharma & Biotech Regulations

> Product Development, Testing & Implementation

PROFESSIONAL EXPERIENCE:

FIRST PRIORITY INC., Elgin, Illinois (The animal health

industry's premier manufacturer and supplier of generic

pharmaceutical products featuring the Priority Care line.)

3/1998 to 11/2009

Vice President of Operations

Provided leadership and direction for all operational

functions in the development, manufacturing and

distribution of pharmaceutical animal care products. Full

accountability for the strategic planning, turnkey

production, multi-department team management and

product turnaround with a focus on quality control, cost

reduction, regulatory compliance and successful

forecasting. Liaison to FDA, EPA and DEA officials, other

state and federal agencies, and internal sales, marketing

and regulatory personnel.

* Maintained compliance with all cGDPs, cGMPs, cGLPs,

SOPs, FDA guidelines and federal regulations via master

validation, quality systems, quality documentation,

change management, supplier evaluation, validation and

calibration programs.

* Supervised the validation of all laboratory and plant

equipment, including electronic document management

systems, distributed control systems, data acquisition

systems and PLCs.

* Coordinated all evaluations, inspections, validations,

auditing, testing, reviews, validations and investigations

of raw goods, finished goods and ANDA submissions,

including:

> Quality Assurance Audits

> Quality Assurance Software Validations

> Supplier Audits & Evaluations

> Compliance Audits & Evaluations

> Laboratory Error Investigations

> Laboratory Compliance Internal Audits

> Release Specifications Testing

> Standard Operating Procedures Review

> Data Verification

> Method Validation Reviews & Inspections

> Computerized Lot Tracking Systems

> Product Batch Record Review Systems

> Analytical Methods Review

> Chemical & Physical Evaluation of New Drugs

> Productivity Monitoring Systems

> Chemical & Physical Methods Evaluations

> Annual Product Reviews

> Internal Compliance Auditing Procedures

> Raw Materials Testing

> Internal Disease Management Protocol Reviews

> In-process Materials Testing

> Quality Assurance Evaluation Procedures Review

> Inventory Level Monitoring

> Equipment & Process Validation Protocol Auditing

Highlights:

-- Improved annual service levels 40% by implementing JIT

(just-in-time) to improve manufacturing flow and

developing a Brite Stock system.

-- Achieved significant cost savings by implementing in-

line quality inspections and process validations, and

negotiating long-term supplier contracts.

-- Developed new quality control review processes,

including test methods, validation protocols,

preformulation studies, stability requirements and

release criteria for final product testing.

-- Successfully coordinated the building/development and

start-up of of new QC/QA laboratory with a 10-member

team and state-of-the-art equipment.

QUINTILES (Formerly Oak Grove Technologies), Mundelein,

Illinois (Global provider of professional services,

information and validation partnering solutions to the

pharmaceutical, biotechnology and healthcare industries.)

2/1997 to 3/1998

Vice President of Validations

Oversaw and directed the QA review and approval of

laboratory instrument qualification protocols for this

validations consulting company specializing in

pharmaceuticals and medical devices. Scope of

responsibility included determining control system

content for lab instrument protocols, executing control

system sections of lab instrument protocols and bringing

instrumentation into 21 CFR Part 11 compliance.

* Interfaced with laboratory instrumentation vendors to

administer and evaluate vendor performed qualifications.

* Mentored new and existing engineers, and provided

cross-training to ensure team versatility in a rapidly

evolving marketplace.

Highlights:

-- Featured for "bringing new ideas to validation" and

"being a mentor" in the July 1998 Medical Device &

Diagnostic Industry magazine as a "Validation Expert: On

the Cutting Edge".

JACOBS ENGINEERING GROUP INC. (Formerly Sverdrup),

Chicago, Illinois (Award-winning design/engineering

consulting firm specializing in modern process plants for

clients in industrial, commercial and government sectors,

including the pharmaceutical and biotechnology

industries.)

12/1996 to 2/1997

Director of Validations

Responsibilities similar to position described above

(Quintiles / Oak Grove Technologies).

AMERSHAM MEDI-PHYSICS, Arlington Heights, Illinois

(Manufacturer of radiopharmaceutical products for the

human health care sector.)

2/1995 to 12/1996

Validation Manager

Directed validation programs for the operations group at

two manufacturing sites (North Arlington Heights, Illinois

and South PLainfield, New Jersey). Responsible for all

validation functions while managing the calibration

department at both facilities, ensuring the creation and

administration of validation master plans, and progress

toward validation goals. Liaison to FDA, Drug Regulatory

Affairs, director of operations, supervising manager, QA

department and corporate headquarters.

* Attained compliance with SOPs, cGMPs and state and

federal regulations by interpreting and enforcing current

validation and technology requirements.

* Administered all personnel actions for the department,

including assignment delegation, performance appraisals,

human asset reviews and career ladders/planning.

* Developed and managed department operating budget,

including capital expenditure and staffing plans.

* Coordinated accurate record-keeping for validation

programs; reviewed controlled documents.

Highlights:

-- Established new policies for the design and evaluation

of validation protocols for validation master plans.

WESLEY-JESSEN CORP., Des Plaines, Illinois (Manufacturer

of contact lenses for healthcare and direct consumer

markets.)

10/1983 to 2/1995

Sr. Validation Engineer, Calibration Supervisor (2/91-

2/95)

Developed and executed validation protocols consistent

with FDA and company guidelines for sterilization,

formulation batching, computer systems, automated

inspection, automated production and new product

development. Provided leadership and direction for

various groups along with a team of two calibration

technicians.

* Collected and analyzed data, and formulated into

written reports; analyzed work processed and formulated

plans for validations.

* Maintained records and calibration for 1,000 (approx.)

pieces of equipment across several departments;

evaluated the reliability of all validation equipment.

* Negotiated contracts totalling $90,000/year with

outside vendors for calibration services.

Highlights:

-- Developed a Change Control System for implementing

and tracking change controls.

Supervisor: Engineering Pilot Lab (12/89-2/91)

Coordinated daily operations in a laboratory for new

product development, prosthetic lens production,

metrology and participation in process improvement

projects.

* Worked on project teams to improve metrology on key

production parameters.

* Organized cell configuration for prosthetic lens

production.

Highlights:

-- Reduced $55,000 in annual costs by redesigning and

implementing a new production process step.

-- Created and managed a centralized calibration service

for all calibrated equipment.

Promoted through a series of progressively responsible

positions, including Maintenance Leadperson, Production

Supervisor, Lead Production Supervisor and Final

Packaging Manager, prior to corporate downsizing and

subsequent transfer to the engineering group.

EDUCATION:

INDUSTRIAL ENGINEERING COLLEGE OF CHICAGO, Chicago,

Illinois

B.S. Industrial Engineering, 3/1991

Dear Hiring Administrator:

Please accept the enclosed resume as my expressed

interest in exploring opportunities with your

organization's operations management team. I am

confident that my 25-years of operations, validation and

engineering experience in the animal and human

pharmaceutical healthcare industries will be an asset to

your business goals.

I offer extensive experience as a V.P. of Operations for

First Priority Inc., a leading manufacturer of animal

pharmaceutical products. Throughout my career I have

implemented numerous initiatives and practices resulting

in improved profit margins, greater regulatory

compliance, increased productivity and reduced costs. I

consistently monitor workflow to ensure optimum

utilization of resources while actively maintaining quality

standards. I excel at appropriately allocating resources,

implementing and training employees in best practices,

and clearly communicating objectives to meet and exceed

established goals.

In addition to these professional qualifications, please

consider these personal characteristics:

* Organization - Excellent organization and time

management skills when strategically delegating

responsibilities in accordance with daily workflow

priorities; ensures the completion of all tasks under

deadline.

* Communication Skills - A diplomatic and articulate

communicator when directing multi-level and multi-

cultural employees, negotiating with outside vendors and

interfacing with corporate officers.

* Problem-Solving - Demonstrated success in recognizing

and responding to situations affecting internal employee

relations, evaluating production options and effectively

implementing principles to meet demand.

Realizing that this summary only partially communicates

the benefits I can provide you, I would appreciate the

opportunity to speak with you personally. Thank you for

your consideration.

Kind regards,

Ralph McKenzie

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