JEANETTE M. ZERELLA

(Cell) 631-***-****

(Email) abkkhk@r.postjobfree.com

SUMMARY: 34 years experience as a Quality Professional in

Medical Devices/ Pharma/BioTech/Aerospace Industries

EXPERIENCE:

8/12 - Present PRESIDENT

Transcendental Supplies, Inc., Patchogue, NY

*Started a Medical Device Distributor of Dental Products.

1/09 - 8/12 DIRECTOR OF QUALITY SYSTEMS

Clintrak Clinical Labeling Services,dba Fisher Clinical

Services/ThermoFisher Scientific, Bohemia, NY

* Responsible for a quality staff of 25 in a cGMP

environment producing clinical trial labels for the top

pharmaceutical companies world wide

* Exceptional First Time Right results in Label Quality

for the site 6 DPM in the history of Clintrak

* Reorganized the department and level of quality to bring

a higher standard of compliance

* Updated SOPs, created work instructions, assessing and

redefining positions for the needs and growth of the

organization

* Configured and validated new Learning Management System

for all corporate wide staff level training

* Developed an internal auditing program comprised of

operational internal staffing

* Development of Supplier Quality Program for the site soon

to go to other sites in NA

* Global Validation Team Lead for Training Management

Software from Plateau.

* Coach and Mentor to staff to enhance development and

succession planning.

5/03 - 12/08 AREA DIRECTOR OF QUALITY & REGULATORY AFFAIRS

GAC International dba Dentsply International, Bohemia, NY

* Took an Orthodontic Medical Device division from ISO 9002

to ISO 13485:2003 & ISO 9001:2000 in 9 months.

*Revised the entire QA system, including manuals,

procedures, work instructions, DMR, labeling systems to new

regulations for an international company.

* Reduced inline inspection by 24% through Lean concepts of

cross-training.

* Prepared divisions to the upgraded regulations in

Mexico, Wisconsin, Florida, Georgia & Alabama divisions.

* Responsible for a staff of approx. 50 in a 150 Mil +

division of a 2 billion and growing organization.

* Established compliance with corporate procedures and

audits to FDA 820, Canadian & MDD, Japan (PAL) & China

regulations

* Responsible for full launching of new products from

conception through design and development to corporate

compliance requirements and approvals (510K submissions).

* Provide training to the organization to bring awareness

of quality, safety & environmental requirements.

7/00 - 5/03 DIRECTOR OF QUALITY ASSURANCE

B/E Aerospace, Holbrook, NY

* Develop annual strategic plans for QA/QC/Testing in-line

with corporate objectives.

* Developed & submitted Malcolm Baldrige application for

2002.

* Developed, implemented & received approval for an

updated QA System of Procedures & Work Instructions to

ISO9001:2000 & AS9100 requirements from the FAA & our

customers.

* Developed a Dock-To-Stock program with FAA approval to

reduce incoming material inspection by 30%.

* Designed & implemented QA Systems with our operating

system to reduce paperwork flow in a Lean-manufacturing

environment.

* Handle all FAA certification and product approvals.

* Responsible for QA/QC & Testing

of electronic lighting & power systems for commercial and

business aircraft.

1/00 - 5/00 QUALITY ENGINEER, REGULATORY

Varian Electronics Manufacturing, Tempe, AZ

* Contracted to review and assess current conformance to

CGMP's (FDA), ISO-9000, and QS9000 regulatory requirements.

* Reviewing, assessing and implementing process

improvements in line with corporate goals for an electronic

contract manufacturer.

6/98 - 5/99 DIRECTOR, QUALITY ASSURANCE

Blood Systems, Inc., Scottsdale, AZ.

* Implemented and guided compliance to Quality Assurance

Requirements mandated by the FDA & local agencies in the

Blood Banking Industry.

* Director for a staff of 7 direct reports and 25 indirect

reports in 18 centers and 2 laboratories in the Mid-West.

* Directly involved with the software validation of

department databases for tracking deficiency reports.

* Guided compliance in the Information Systems Department

to cover all aspects of software relative to the testing

environment.

4/92 - 6/98 QUALITY MANAGER

Long Island Blood Services, DBA New York Blood Center

Melville, N.Y.

* Implemented and guided compliance to Quality Assurance

Requirements (cGMPs) mandated by the FDA (CFRs 200) & local

agencies in the Blood Banking Industry by significantly

reducing errors and reportable incidents by 75%

* One year ran with no 483's from the FDA

* Created and managed various special projects designed to

reduce operating costs, streamline operational processes

and set-up new systems to monitor supplier's quality

* Design, coordination and implementation of

process/product validation

* Process owner of the corporation's largest revenue

producer (platelet apheresis - $30 million).

10/86 - 4/92 QUALITY ASSURANCE MANAGER

Litton Applied Technology formerly General Instrument

Corporation,

Hicksville, N.Y.

* Directed a staff of 14 Quality Professionals in ensuring

compliance with DOD, Foreign Military programs for Airborne

Electronic Warfare Systems.

* Eliminated in-process inspection and decreased incoming

inspection by approx. 50%

* Created and implemented action plans on production and R

& D programs for Just-In-Time, Statistical Process Control,

Vendor Certification and Quality Improvement Teams for a

Fortune 100 Company.

EDUCATION: Polytechnic University

M.S. Management-Strategic Planning, Quality & Productivity

1996

New York Institute of Technology

B.P.S. Technological Management/Mechanical Eng.

1989

1/12 - Present ADJUNCT FACULTY

SUNY - Stony Brook University - College of Business, Stony

Brook, NY

ASSOCIATIONS: ASQ 1984, RAPS 2003

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