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