Quality Assurance Control

HENRY F. EISNER

** ******* ***** ? Hopewell Junction, NY 12533 ? 845-***-****

(H) ? ********@***.***

Dear HR Department,

Would you consider 3 years of college and 15 years experience at the bench

doing product development?

I am looking for a position in quality, research and development or

manufacturing in the NY Metro Area.

Successfully performed many years of pilot plant and laboratory research

and development of new chemical entities and pharmaceuticals following

SOP's under cGMP, CFR 21 Parts 210 & 211.

Validated and commissioned 3 cGMP pilot plant bays, supporting all IQ, OQ,

and PQ activities at a

capital investment to the company of over 10 million dollars.

Build, operated and maintained chemical development processes on a pilot

plant scale as per

project needs using chemical reactors, condensers, filter dryers, pumps,

spray driers, freeze dryers, mixers, grinders, temperature controllers and

Coperion extruders.

Operation and maintenance of all supporting systems, scrubbers, vacuum

pumps, compressors and chillers

keeping costs in-house and lowering maintenance expenses. Coperion

extruders, Supervised all test and pilot plant equipment maintenance,

repairs and replacement.

Working knowledge of the Code of Federal Regulations 21 Parts 210 & 211, to

ensure quality policies are adhered to and all procedures are followed

according to standard operating procedures and cGMP's.

Managed the Q.C. Department and overseeing twenty-eight production lines,

writing, editing and appending all standard operating procedures and change

controls.

Conducted all SOP training for quality control, warehousing, and receiving

personnel. Approved all reconciliation's of finished products prior to

shipping to assure product quality.

Conducted internal quality audits of manufacturing, warehousing and

printing departments and managed all of the company's product retention

audits to assure quality production. Quality assurance supervision of all

consumer testing, to insure a quality product gets into the customers hands

for home use testing.

Appended, consolidated, and wrote specification for new products and raw

materials included in the

companies common specification system meeting project deadline

requirements.

I look forward to the opportunity to discuss this with you further, please

feel free to contact me.

Sincerely,

Henry F. Eisner

HENRY F. EISNER

26 Bradley Drive ? Hopewell Junction, NY 12533 ? 845-***-****

(H) ? ********@***.***

OBJECTIVE

To obtain a position in a research and development, quality control,

laboratory or chemical engineering

environment where my creativity, technical skills and result oriented

approach will make a difference.

SUMMARY OF QUALIFICATIONS

Experienced Technical Specialist in the pharmaceutical and food engineering

industries, from the lab bench to commercialization. Excellent computer

skills and working knowledge of many software applications and programs.

Quality control and quality assurance experience in all phases of cGMP and

cGLP. Skilled trouble shooter with computers, laboratory equipment and

manufacturing equipment.

RELEVENT SKILLS AND EXPERIENCE

Computer Skills

. Microsoft Windows . Microsoft Excel . Microsoft Word .

Microsoft Power Point

. Microsoft Outlook . Lotus Notes . Lotus 123 . Lotus

Word Pro

Supervisory Experience

. Ensuring the company quality policies are adhered to and all procedures

are followed according

to FDA guidelines of GMP's, under the Code of Federal Regulations 21

Parts 210 & 211.

. Managing Q.C. Department and overseeing twenty-eight production lines.

. Writing, editing and appending all standard operating procedures and

change controls.

. Conducted all SOP training for quality control, warehousing, and

receiving personnel.

. Approval of all raw material and packaging receiving to assure correct

manufacturing.

Professional Experience

Pilot Plant Specialist - Flavor Engineering and Technology

Symrise Flavors and Fragrances, Teterboro, NJ 07608 12/05 - Present

Quality Assurance Manager - Food, Drug and Cosmetic Packaging

Ultra-Seal, Creative Contract Packaging, New Paltz, NY 12561 10/04-5/05

Technical Specialist - Chemical Development - Pilot-Plant / Kilo Lab

Purdue Pharma L.P., International R&D, Ardsley, NY 10502 1/01-8/04

Software Engineer - Level II Technical Support

IBM Corporation, Poughkeepsie, New York 126**-****-****

Senior Laboratory Technologist - Research and Development

Kraft/General Foods Technical Center, Tarrytown, New York 105**-****-****

Education

IBM Experienced Programmer Education

IBM Mainframe Software Engineer

IBM Technical School, Poughkeepsie, NY

Computer Information Systems, Pace University, Pleasantville, NY

Certification Degree: 84 credits: BASIC, COBOL, C, and C++ Programming,

Information Systems Analysis and Design, and Business Data Communications.

AAS Medical Laboratory Technology

SUNY Valhalla, Westchester Community College, Valhalla, NY

HENRY F. EISNER

26 Bradley Drive ? Hopewell Junction, NY 12533 ? 845-***-****

(H) ? ********@***.***

ACHIEVEMENTS

Management

. Working knowledge of the Code of Federal Regulations 21 Parts 210 &

211.

. Ensured quality policies are adhered to and all procedures are followed

according to

Standard Operating Procedures and cGMP's.

. Managing Q.C. Department and overseeing twenty-eight production lines.

. Writing, editing and appending all standard operating procedures and

change controls.

. Conducted all SOP training for quality control, warehousing, and

receiving personnel.

. Approval of all reconciliation's of finished products prior to shipping

to assure product quality.

. Conducted Internal Quality Audits of manufacturing, warehousing and

printing departments.

. Managed all of the companies product retention audits to assure quality

production.

. Quality assurance supervision of all consumer testing, to insure a

quality product gets into the

customers hands for home use testing.

. Appended, consolidated, and wrote specification for new products and

raw materials included in the

companies common specification system meeting project deadline

requirements.

Operations

. Pilot plant and laboratory research and development of new chemical

entities and pharmaceuticals

following SOP's under cGMP, CFR 21 Parts 210 & 211.

. Validated and commissioned 3 cGMP pilot plant bays, supporting all IQ,

OQ, and PQ activities at a

capitol investment to the company of over 10 million dollars.

. Building, operation and maintenance of chemical development processes

on a pilot plant scale as per

project needs using Coperion extruders, chemical reactors, condensers,

filter dryers, pumps, spray driers, freeze dryers, mixers, grinders and

temperature controllers.

. Operation and maintenance of all supporting systems, scrubbers, vacuum

pumps, compressors and chillers

keeping costs in-house and lowering maintenance expenses.

. Supervised all test and pilot plant equipment maintenance, repairs and

replacement.

. Designed, developed, and implemented new cost reduced processes for

ongoing cost productivity projects

saving $3,000,000 annually.

Chemical and Process Development

. Successfully conducted extensive research and development on kilo-lab

and pilot plant scale up projects in analgesic technologies.

. Extensive experimentation into the efficiencies surrounding chemical

development and chemical processing.

. Scale up projects from the laboratory bench to finished product

commercialization.

. Set-up, operation, preventative maintenance of the pilot plant

processes and equipment to ensure proper validation during system start-

up.

. Conducted research into raw material and finished product storage

stability studies to guarantee a quality product.

. Investigated, tested and validated new equipment and processes.

. Produced pilot plant product for experimentation and animal testing.

. Successfully scaled up validated and started a process improvement

project on OxyContin .

. Developed and optimized processes for new chemical entities and

intermediates.

Safety

. Hazardous Material Response Specialist - trained by Docimo &

Associates, Stamford, CT.

. Emergency Response Team member, trained by FDNY in Hazmat Rescue.

. NYS Emergency Medical Technician / defibrillation training and CPR.

Contact this candidate