Engineer Manager
Resume:
DIONNA M. DI PIERRO
Kalamazoo, MI 49009
PROFESSIONAL EXPERIENCE
Pfizer, Kalamazoo, Michigan
Quality Operations Specialist - 06-10-Present
Investigate human heath product and medical device complaints and
animal health product complaints
Provide formal responses regarding inquires into product quality
Review product batch records for quality matters related to
production, filling and packaging
Test retained product samples from specific lots for quality
Evaluate returned product samples for quality defects
Develop reports regarding inquiries into product quality and defects
Review lot history, product specifications and deviations for
potential product quality impact
Assess complaint history for trends in product defects
Compile quarterly complaint and trend data to present to the Site
Quality Leadership Team (SQRT)
Collaborate with production in order to compile data regarding
packaging and filling processes
Key Accomplishments:
. Currently leading a Green Belt Project to reduce the costs
associated with Epsilon Valve failures (estimated savings -
$50,000/yr).
. Participated in a Black Belt Project to reduce the number of
complaints associated with one product line.
. Member of a Black Belt Project team to develop a process to utilize
product complaint trending in order to ensure product quality,
patient safety, and continuous improvement.
Pfizer, Kalamazoo, Michigan
Reliability Technician (Compliance) - 01/05 - 06/10
Participate in risk classification of equipment and instrumentation
for the purpose of establishing PM
Monitor change control documents for production and maintenance
related changes
Review General Change Requests (GCRs) and populate required fields for
documentation purposes
Update CMMS to meet regulatory and reliability needs for equipment
and instrumentation
Communicate with and provide technical assistance to Maintenance
Technicians and Enablers
Ensure conformance on the use of compliance policies related to
maintenance and change control
Attend maintenance and operations interface meetings to support
upcoming projects
Generate Data Asset Changes (DACs) to facilitate documentation
changes within the maintenance organization
Monitor monthly GMP delinquency reports and resolve all items prior
to the month's end
Initiate Incident Database (IDB) reports for GMP calibration failures
or GMP non-compliance issues
Knowledgeable in GMPs and 21CFR Part 11
Provide SOP, safety, and other required training to maintenance team
members
Key Accomplishments:
. Participated in a Green Belt project to streamline the RFPM
process. Developed and delivered
training to impacted colleagues for the new Data Asset Change (DAC)
that was a result of this project.
. Led a significant cost savings project in B-89 to eliminate the
number of fermentor valves that
were being replaced annually: Cost savings amounted to $64,000, in
addition to reduced annual PM costs.
. Participated in a Black Belt Project to reduce the number of
flanged joint leaks on site.
. Part of a four-member team tasked with delivering Work Management
Simulation Training across
the site: To date over 230 colleagues have successfully been
trained.
. Served a two-year term on the Engineering Volunteer Committee: Led,
planned and organized two
projects for non-profit organizations - over 100 volunteers
attended.
. Member of the EAMS user team: Ran test scripts of the newest
version of the software.
. Participated in a Kaizen Event to improve the workflow scheduling
process on the site.
Pharmacia/Pfizer, Kalamazoo, Michigan
Engineering Validation Technician - 10/01 - 01/05
Compiled necessary documentation to incorporate into
installation/operational qualifications
Evaluated electronic change permits for impact on equipment
qualification
Participated in maintenance-driven projects to generate and support
all documentation efforts
Monitored Electronic Change Control System
Acted as an Engineering Systems Qualification liaison among
engineering, maintenance, operations, and quality
Reviewed Piping and Instrument Diagrams and Loop Drawings
Collaborated in developing new work-flow processes to capture
required documentation
Provided training on non-capital documentation efforts
Engineering Support Technician- 3/01 - 10/01
Supported five engineering and maintenance managers
Compiled and generated spreadsheets and charts to accurately portray
budget information
Created and assembled monthly charts and graphs binders
Generated and tracked expense reports and check requisitions
Reviewed and submitted invoices for employees' hours
Assisted with web development for the engineering and maintenance
group
BCI Net, Bliss, Fitness First, Tranquility, Three Rivers, Michigan
Graphic Designer/Marketing - Contractual Freelance Work - 1/01 - 3/01
Conceptualized marketing materials for four organizations
Designed logos, capability brochures, trade show materials,
presentations, and other various marketing materials
Assisted with the planning of a "grand opening" marketing concept for
a new organization
Directly collaborated with company owners on all editorial aspects of
marketing materials
Conferred with printers to ensure a high quality printed product
United States Postal Service, Kalamazoo, Michigan
Supervisor, Human Resources - 9/99 - 8/00
Responsible for aiding in hiring over 300 employees
Reorganized personnel records to comply with USPS regulations
Managed employee's compensation and benefits program
Administered employee testing and training programs
United States Postal Service, Kalamazoo, Michigan
Administrative Assistant - 1/97 - 9-99
Created reporting system to provide statistics to facility manager,
industrial engineer, and headquarters office
Controlled all financial procedures in a facility with over 500
employees
Developed a filing system to meet USPS compliance regulations for
audits
Directly reported to the facility manager and industrial engineer
Assisted industrial engineer in LAN administration
Responsible for obtaining information from USPS corporate mainframe
Maintained employee incentive program
Organized seven successful blood drives for the American Red Cross and
the USPS
EDUCATION
Davenport University
Masters in Business Administration, focus in Strategic Management - GPA 4.0
- Summa Cum Laude
Davenport University
Bachelors Degree in Business Administration - GPA 3.97 - Summa Cum Laude
Kellogg Community College
Associates Degree in Graphic Design - GPA 3.93 - Summa Cum Laude
SOFTWARE APPLICATIONS
. MS Office Suite
. Cognos
. TrackWise
. Oracle based CMMS
. Minitab
. Documentum
. Electronic Change Control Systems
. Deviation and Complaint Reporting Systems
ACCOMPLISHMENTS
. 2009-2010 Pfizer Engagement Award
. Received two graduate honors awards for academic excellence
. Volunteered over 600 hours to non-profit organizations
. Member of Phi Kappa Theta Honor Society
. Completed management courses: How to Build High Performance Teams,
Managing People, Managing and Achieving Organizational Goals,
Interpersonal Communications and Understanding Personality Styles,
Franklin Covey training, Personal Exploration Workshop, Seven Habits
of Highly Effective People
. Member of the Board of Directors for The Adventure Centre at Pretty
Lake for two years
. Team Captain for four fundraising events for cancer research
INTERNAL REFERENCES
. Douglas Hicks - Sr. Manager/Team Leader - 269-***-****
. Donald Stull - Team Leader - 269-***-****
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