Manager Quality Assurance

**** ***** ****, **** ********, NJ *****

856-***-**** ******@*******.***

SUMMARY OF QUALIFICATIONS

. Recognized leader

. Superior problem solving and creative solution development skills

. Able to perform above expectations in high-pressure, deadline-oriented

environments

. Strong communicator with excellent writing, presentation and computer

skills

. Proactive mind, rigorous work ethic, and a spirit of service

WORK EXPERIENCE

INNOVASYSTEMS, INC. - Project and Technical Support Manager, Moorestown,

NJ, February 1998 - present

InnovaSystems engineers and builds Custom Automation for the Pharmaceutical

Industry for testing Metered Dose Inhalers and Nasal Spray Products

. Managed all aspects of automation project planning including sourcing,

inventory control, scheduling assembly, factory acceptance testing and

shipping

. Authored and maintained documents such as SOP's, User's Guides,

Installation Qualifications, Operational Qualifications and

Factory Acceptance Testplans for all custom automation products

. Conducted Performance Qualification studies for Pharmaceutical R&D and

QC laboratories for Metered Dose Inhalers and Nasal Spray Pumps in a

global market

. Managed all aspect of Customer Support including troubleshooting

problems, scheduling service calls for all support engineers,

authoring and maintaining all service documents

. Coordinate the maintenance and calibration of all service equipment

DRUG SCREENING SYSTEMS, INC. - Manufacturing Manager, Casco, ME (Formerly

Blackwood, NJ, purchased by Casco Standards June 1997) October 1989-

June1997

Drug Screening Systems produced a urine immunoassay for the pre-employment

testing for drugs of abuse

Manufacturing Manager

. Scheduled workload for 30-50 production employees

. Inventory control of all raw materials, in process materials and

final product

. Authored production batch records, SOPs, and Quality Assurance

Protocols

. Maintenance and troubleshooting of all production equipment

. Implemented QC sampling and process changes resulting in

significant cost savings

. Key player in transition of Drug Screening Systems to Casco

Standards

R&D Manager

. Managed the development of Micro line Screen Immunoassay for drugs

of abuse

. Developed QC tests and SOPs for manufacturing

EM Science - QC Scientist, Gibbstown, NJ, October 1988-October 1989

. Quality Control testing of CK and CK-MB tests

. Creation of QC test protocols

CHILDREN'S SEASHORE HOUSE- Scientist, Philadelphia, PA, September 1987-

October 1988

. Clinical studies for treating children with inborn errors in

metabolism

. Rodent surgery, blood, and tissue sampling

CELGENE CORPORATION- Associate Scientist, Warren, NJ, September 1985-

September 1987

. Isolation of bacterial cell lines for fermentation of chemical

intermediates

. HPLC, both analytical and production scale up

EDUCATION

Douglass College, Rutgers University, Bachelor's Degree, Biochemistry,

May 1985

TECHNICAL SKILLS

MS Professional Office Suite, OpenOffice Suite, BusinessWorks, LaTex

(Publishing Program)

References furnished upon request

Contact this candidate