+

REGGIE SMITH

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

Houston, Tx. 77090

281-***-**** email y63rrx@r.postjobfree.com

OBJECTIVE

I seek a corporation in need of a driven individual, capable of tooling and tuning

the department up to maximum efficiency in order to help coordinate dynamic growth,

while implanting and overseeing full compliance with FDA, AAMI, CLIA, USP, ISO,

GMP and all other regulatory requirements. As a highly experienced leader I have a wealth

of experience in electronics, pharmaceuticals, medical devices, diagnostic products,

sterilization, (steam, Ethylene Oxide and radiation), and all aspects of quality control.

CREDENTIALS

TRELLEBORG CRP 2007- HOUSTON, TEXAS

PRODUCTION SUPERVISOR

Mixing and batching of syntactic and polymer products for the manufacture of offshore flotation modules.

THE FORUM AT THE WOODLANDS 2005- 2007

ENVIRONMENTAL MANAGER

In charge of the building services and maintenance group for an upscale retirement community.

Cut the monthly supply budget $7000 by narrowing the number of suppliers and using the

Ecolab mixing system.

SYNCOR ADVANCED ISOTOPE, ( CARDINAL HEALTH ) 2001-2005 FT. LAUDERDALE, FL.

QC SUPERVISOR, PET TECH I

Manufacture and vialing of FDG18, operation of Cyclotron, release of product,( GC, LAL, CHEMICAL PURITY )

ISO-TEX DIAGNOSTICS 1999 -2001 FRIENDSWOOD, TEXAS

ASSOC. HEALTH PHYSICS SPECIALIST

Responsible for the manufacture and filling of Radiopharmaceuticals by labeling of antibodies

with customer specified Isotopes I-131, I-125&123, I-111 and Y-90. Confirmation

of specifications are done by dose calibrator, HPLC, flame, albumin concentration

and chloride. Duties also included the assurance of compliance with NRC and FDA

regulations.

RADIATION TECHNOLOGY ( STERIGENICS ) 1993-1998 SALEM, NJ

PLANT MANAGER

My first challenge was to make the facility compliant to the new NUCLEAR REGULA-

TORY COMMISSION guidelines, that accomplished, I hired staff, ten operators, two

technicians and after one month of training at NORDION RADIATION ACADEMY in

CANADA, I returned to get the plant in operation. In SEPTEMBER 1993 we opened for

business, ahead of schedule. The opening process included letting waste removal, Cobalt

60 purchase, transportation, maintenance and material handling contracts, all accomplished under

budget. RTI was a contract sterilization facility with such clients as Estee Lauder, Kendall Medical,

Ortho and Kiwi polish. Created the dose mapping system for all products.

SURGIMEDICS 1987-1993 ( NOVOSCI ) THE WOODLANDS, TEXAS

PRODUCTION SUPERVISOR

Hired as supervisor for the second shift, in six months was promoted to section supervisor.

Was put in charge of a total plant relocation project, made the move to a new facility with

no loss of productivity. Productivity improved by 15% in my first six months using

reengineering, KAN BAN, JIT, WORLD CLASS MANUFACTURING. Promoted to

Plant Manager for the Ethylene Oxide sterilization division in 1990. Converted two 12/88

Ethylene Oxide chambers to100% Ethylene Oxide, computer controlled ( ANTARES

SOFTWARE). Wrote GMP manual, created and validated customers fractional cycles.

We were a medical device manufacturer that became ISO certified in 1992.

AFFILIATIONS/CERTIFICATIONS

AUTHORIZED USER, RADIOACTIVE MATERIALS, STATE OF TEXAS

ASEPTIC PROCESSING, COLLEGE OF PHARMACY, UNIVERSITY OF TENNESSEE

CERTIFIED COACH, AMERICAN MANAGEMENT ASSOCIATION

SUPERVISOR II, GULF COAST BLOOD CENTER

SOCIETY OF MANUFACTURING ENGINEERS

SOCIETY OF PLASTICS ENGINEERS

DEVICE MANUFACTURERS ASSOCIATION

EDUCATION

TEXAS SOUTHERN UNIVERSITY--- BIOLOGY

HOUSTON, TX

UNIV OF TENNESEE--- PHARMACEUTICAL MANUFACTURING

MEMPHIS, TN

NORDION ACADEMY--- RADIATION

MONTREAL, CANADA

US ARMY--- MEDICAL LAB SPECIALIST, BLOOD BANK TECH

SALEM COMMUNITY COLLEGE--- FOXPRO,PLC,S, LOTUS

SHUMWAY COMPUTERS--- MS WORD,EXCEL

Contact this candidate