DIANE KASNER BOVINO

130 Stanton Road, Flemington, NJ 08822

T: (908) 303-5667 / dbd7749c@westpost.net
EXPERIENCED QUALITY ASSURANCE MANAGER
Successful manager of corporate quality management systems with over 15 years of
related industry experience including ISO and regulatory compliance, internal a
nd external auditing, supplier management, corrective and preventive actions, co
ntinuous improvement, document control, and training.
Qualified project manager with proven track record leading interdisciplinary pro
ject teams with core competencies in project planning, process mapping, change c
ontrol and implementation, project tracking, technical communications, and train
ing.
AREAS OF EXPERTISE
* Problem Solving
* Assessment & Analysis
* Leadership
* Process Improvements
* Decision Making
* Relationship Building
* Planning
* Organization
* Communications
PROFESSIONAL EXPERIENCE
UNICLEAN CLEANROOM SERVICES, MAPLEWOOD, NJ 07040 2008 - PRESENT
Multi-location cleanroom services provider serving the medical device, pharmaceu
tical, biotech, electronics, and related industries.
Division Quality Assurance Manager
Lead the implementation and maintenance of the ISO 9001 registered Quality Manag
ement System for the $18M division currently comprised of four locations and sup
porting the start-up of two additional locations. Command knowledge of ISO 9001,
ISO 13485, and cGMP compliance.
* Achieved division-wide ISO 9001:2008 re-certification with zero non-conformanc
es.
* Successfully completed 10+ customer audits each year to demonstrate program co
mpliance to ISO and cGMP requirements.
* Improved internal audit program to ensure objective evidence is used as the ba
sis for evaluations and conducted the quarterly internal audits with all locatio
ns.
* Implemented document controls by revising SOPs and Work Instructions to comply
with current industry standards; authoring testing reports and technical suppor
t documents; and managing retained division-wide records.
* Liaised with customers regarding their controlled area requirements such as cl
eanroom classifications to ISO 14644 standards, gowning protocols, contamination
controls, room certifications, and environmental monitoring.
* Initiated, investigated, and closed Corrective Actions /Preventive Actions aft
er completing root cause analyses and ensuring effectiveness, as well as address
ing all customer complaints.
* Administered division supplier qualification records, conducted supplier audit
s, updated Approved Supplier Lists, and tracked supplier performance with an ann
ual report card.
* Lead the quarterly Executive Management Team meetings including review of qual
ity metrics.
* Created and maintained the library of critical quality related product specifi
cations.
* Developed quality system training and conducted sessions on technical requirem
ents, program updates, and procedure implementation including web-based conferen
cing for remote location managers and staff.
* Directed implementation of biocontamination control program in compliance with
ISO 14698 requirements.
* Updated gamma sterilization program to ensure compliance with ANSI/AAMI/ISO 11
137 requirements and oversaw quarterly dose audits for all locations.
* Launched ethylene oxide sterilization program in compliance with ANSI/AAMI/ISO
11135 requirements including validation studies, procedures, and start-up produ
ction.
* Assisted Environmental, Health, and Safety program implementation with Job Haz
ard Analyses and respirator training requirements.
OTHER PROFESSIONAL EXPERIENCE
* SANDIA NATIONAL LABORATORIES - Designed and conducted a comprehensive internal
audit program to ensure compliance with applicable federal and state Environmen
tal, Health, and Safety regulations as well as development of a site-wide Correc
tive Action Plan.
* U.S. BRONZE CORPORATION - Coordinated Certificates of Analysis program for QC
Lab and managed product specifications.
* PUBLIC SERVICE OF NEW HAMPSHIRE - Managed project team of 25 engineers respons
ible for the development and maintenance of controlled plans and procedures. Pri
mary liaison between federal regulators, corporate management, and state officia
ls in three states to coordinate communications, inspections, and general inform
ation exchange on critical path project leading to operating license for $6.3 bi
llion plant.
* PSE&G OF NEW JERSEY - Developed plans, procedures, technical reports, and inst
ructional materials to support operations. Presented training in radiation scien
ce, chemistry, dose assessment, contamination control, environmental monitoring,
emergency response, General Employee, and Right-to-Know.
* STONE & WEBSTER ENGINEERING - Wrote technical reports, regulatory responses, s
ystems manuals, standard operating procedures, and instructional materials.
EDUCATION
The College of New Jersey, Ewing, NJ
Master of Arts in Teaching
Rutgers University, Douglass College, New Brunswick, NJ
Bachelor of Arts (32 credits in Biology/ Chemistry)
Corporate Professional Development: Project Engineer Training, Technical Supervi
sory Skills Program, Instructor Certification Program
AFFILIATIONS
The Grammar School at Stony Hill - Board of Directors
Readington Township Schools - Math Curriculum Review Committee/ HSA - Vice Presi
dent
ASQ Member