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Project Manager Quality

Location:
Cleveland, TN, 37312
Posted:
November 01, 2010

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Resume:

L. Kevin Swafford

**** ********** ** ** . *********, TN 37312 . 423-***-****

Summary

Over 15 years of Management, Supervisory, and Support Staff experience in

diverse, complex, and demanding fields, including synthesized silicates,

OTC and healthcare products, supply chain management, and a variety of

laboratory environments including radiochemical. Recent management

experience leading successful initiatives to improve organizational

performance, reduce cash costs, and meet overall group (Global) objectives.

Detailed Experience

J.M. Huber Corporation Etowah TN

Quality Assurance Manager: September 2008 - Present

. direct oversight of 11 employees and a departmental budget of

$1.3 million

. site owner of ISO 9000 certification; successful recertification

in September 2009

. responsible for entire Quality Management System at Etowah site

. directly responsible for the Internal Auditing Program at Etowah

. responsible for site Analytical Laboratory, Microbiological

monitoring program, and all GMP functions

. reduced non-right first time instances over 55% in 2009 at a

savings of over $600k

. primary contact and host for all Vendor and Agency audits

. facilitate global product quality studies among all Huber silica

sites

. serve as Document Control Unit for the facility

. drafted defined progression plan for all site Quality personnel

. directly responsible for customer complaints, including root

cause analysis

. perform on-site qualification audits for key suppliers

. conduct site-wide GMP training

Schering-Plough Healthcare Products Cleveland TN

Quality Systems Specialist: June, 2006 - September, 2008

. directly responsible for creation, review and/or approval of a

variety of lifecycle documents including SOPs and

Validation/Qualification protocols

. site project manager for new laboratory chromatography

application

. oversaw all facets of site Quality Operations calibration

program and harmonized metrics among Analytical, Microbiology,

and In-Process laboratories

Product Complaint Specialist: August, 2003 - June 2006

. coordinated consumer complaint investigations including third

parties

. provided monthly metrics to Global Quality detailing consumer

complaint activity

. facilitated quarterly consumer complaint trend review meeting to

include all North American HCP sites and Consumer Relations

. SAP and TrackWise user

Chemist: March, 1999 - August, 2003

Job responsibilities:

. performed quality control analyses on a variety of products via

HPLC, GC, and Atomic Absorption chromatography

. served as primary analyst for tablet dissolution and analysis

. performed final disposition of products for release to market

Westside Lawn and Garden, LLC

Owner: March, 1997 - June, 2000

. established and managed retail garden/landscaping center

Lockheed Martin Energy Systems, Chemical & Analytical Sciences

Division

Oak Ridge TN

Chemist: March, 1992 - June, 1996

Job responsibilities:

. worked as a radiochemical separations analyst in a high level

radiological materials laboratory

. performed analyses and recorded measurements for daily quality

control samples as well as site NPDES activities

. calibrated and maintained nuclear measurement instrumentation

United States Marine Corps Reserves

Motor Transport Specialist: August, 1994 - July, 1998

. six months active duty and remainder of enlistment in the active

reserves

. Honorably Discharged

Education

University of Tennessee-Chattanooga

B.A., Chemistry, 1991

Certifications/Professional Associations

. International Pharmaceutical Excipients Association (IPEA) Quality

Auditor Training, October, 2009

. Six Sigma Green Belt Training and Certification, Chattanooga State,

January, 2006

. Certified Quality Auditor, ASQ, March, 2004

. Member, American Society for Quality

References Upon Request



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