Quality Assurance Engineer

JEFF SUTHERLAND

*** ******* ***** ***** ( Gainesville, Georgia 30504

972-***-**** ( *************@*******.***

QUALITY ASSURANCE MANAGER / QUALITY ENGINEER / QUALITY AUDITOR

Accomplished Quality Professional, with versatile experience across

pharmaceutical, chemical, medical technology, packaging, and consumer goods

industries. Areas of expertise include:

Quality Assurance Management ( Quality Audit Management ( Regulatory

Compliance ( New Product Launches

Verification & Validation Procedures ( Process Engineering ( Technical

Writing ( Procedure Implementation

ISO 9001:2008 ( Cross-Functional Team Leadership ( Inspection Testing (

Training & Development

Process Improvements ( Customer Relationship Management ( Data Analysis &

Reporting

SUMMARY

Exceptional organizational and analytical skills, with more than 20 years

of experience facilitating successful quality initiatives, improvements,

and product launches. Effective communicator, known for building positive

alliances with customers, colleagues, and regulatory agencies.

Continuously implement company-wide standards and procedures that improve

performance and efficiency while reducing defects and waste.

PROFESSIONAL EXPERIENCE

KIK CUSTOM PRODUCTS, Gainesville, Georgia ( 2008-2009

One of North America's largest manufacturers of both national and retail

brand consumer products; produces leading products for Fortune 500

companies including Gillette, Johnson & Johnson, Kimberly-Clark, and more.

Compliance Manager

Oversaw and ensured plant-wide compliance with FDA regulations and customer

requirements regarding batching and filling of new and existing products.

Maintained Master Validation Plan and implemented studies for new products

and equipment. Managed Internal Audit Program. Monitored results of plant

micro and environmental sampling. Supervised personnel charged with

cleaning and sanitizing batching and filling equipment between products.

Resolved customer complaints and monitored corrective action activities.

Frequently interfaced with customers to review and determine their

batching, testing, and filling specifications.

. Consistently met internal, regulatory, and customer requirements by

effectively analyzing and revising Standard Operating Procedures, formula

changes, and work instructions.

. Implemented efficient procedures for cleaning / sanitization of batching

and filling equipment between products.

NEW-TECH PACKAGING, INC., Memphis, Tennessee ( 2004-2008

Award-winning contract packager and custom corrugate manufacturer.

Quality Manager

Ensured plant-wide compliance with regulatory, customer, corporate, safety,

and training requirements. Oversaw daily activities of Quality Auditor and

Quality Technicians. Continuously evaluated and updated Standard Operating

Procedures. Conducted line clearances and in-process inspections for drug-

related and non-drug packaging. Coordinated disposition of substandard

packaging materials and non-conforming finished goods with customers,

suppliers, and plant personnel. Assisted with production scheduling,

package design, customer service, and interpreting customer product

specifications. Led periodic training sessions related to OSHA regulations

and Good Manufacturing Practices.

. Compiled and introduced company Quality Manual.

CCL CUSTOM MANUFACTURING, INC., Memphis, Tennessee ( 2003-2004

A contract packager of personal care products; acquired by KIK Custom

Products in 2005.

Validations Engineer

Fulfilled contract assignment to develop and implement protocols for Master

Validation Plan.

. Developed and established Cleaning Matrix and procedures for Cleaning

Validation Plan of compounding and contract filling operations.

JEFF SUTHERLAND ( Page 2 ( *************@*******.***

WRIGHT MEDICAL TECHNOLOGY, Arlington, Tennessee ( 2002-2003

Manufacturer and distributor of bio-orthopaedic implants and medical

devices.

Process Engineer

Facilitated all aspects of new product development from design stage to

launch.

. Developed and introduced validation studies and equipment qualifications

to verify that processing methods and equipment operated within

established limits and tolerances.

MIKART, INC. PHARMACEUTICALS, Atlanta, Georgia ( 2001-2002

Recognized leader in providing formulation development, contract

manufacturing, and packaging services to the pharmaceutical industry with

$26.5M in sales.

Validations Engineer

Performed process validation studies to ensure maximum processing

efficiency and regulatory compliance. Coordinated development of new

product submissions with clients, project management, R&D, and production

teams.

. Designed and implemented protocols and studies to define requirements for

sampling, testing, and acceptance criteria.

NSI CHEMICAL GROUP, Atlanta, Georgia ( 1997-2001

ZEP Manufacturing Company merged with Selig Industries and Enforcer

Products to form NSI Chemical Group.

Quality Auditor

Oversaw all facets of quality assurance functions and procedures related to

production and manufacturing of bulk liquids, hand care products, aerosols,

powders, and acid-based products. Compiled findings and presented status

reports to management and plant personnel for corrective action and

continuous improvement. Performed supplier audits and evaluations.

Coordinated disposition of substandard packaging materials and non-

conforming finished goods with customers, suppliers, and plant personnel.

Served as ISO-9000 Internal Auditor.

. Developed and implemented guidelines and procedures for packaging quality

standards and auditing functions.

EARLY CAREER NOTES (full details on request)

SCHERING-PLOUGH HEALTH CARE PRODUCTS, Memphis, Tennessee / Quality

Technician

ZEP MANUFACTURING COMPANY, Atlanta, Georgia / Quality Control Chemist

EDUCATION

Bachelor of Arts, Biology

Harding University, Searcy, Arkansas

ADDITIONAL TRAINING

ISO 9001:2008 Standards

Six Sigma Quality Improvement Methods-Green Belt Training

Baldridge Criteria Training, Greater Memphis Association for Quality

PROFESSIONAL CERTIFICATIONS

Certified Quality Engineer, American Society for Quality

Certified Quality Auditor, American Society for Quality

PROFESSIONAL MEMBERSHIPS

Section Secretary, Memphis Chapter of American Society for Quality (ASQ)

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