Edward J. Dacey Jr.
***** ***** ***, **** *********, Fl 33948
abkq4p@r.postjobfree.com
My career spans both the Quality and Customer Service arenas and is
supported by my skills in chemistry, mathematic, and business. My
experience would fit perfectly in a Quality Control or Assurance position.
I have functioned in the material, inspection, engineering, auditing,
testing, and documentation control areas as both an individual and team
environment.
EXPERIENCE: Quality
Vertex Pharmaceutical Inc.
Sr. QA Specialist (2008 - 2010)
o Review, verify, comment, and approve manufacturing and analytical testing
data generated by CMO during the developmental phase 2/3 of Vertex drug
product candidates.
o Data review and summary of stability data of API, intermediate, drug
product as received form the CMO/CRO.
o Support the activities of labeling and packaging and approving of Vertex
finished products conducted by the various packagers contracted by
Vertex.
o Generate new documentation and systems governing the revision or creation
of new specifications, methods, protocols, or procedures relating to
Phase 2/3 development activities.
o Act as the Quality representative to a cross functional team to resolve
product complaints, OOS issues, or deviations relative to outgoing
quality of materials, process, and product involved in clinical trial and
commercialization of Vertex drug candidates.
Inotek Pharmaceutical Corp. (2005 - 2007)
Company Downsizing
Quality Control Chemist
o Controlled all received tox/clinical samples for shelf-life, clinical,
biological, and non-biological programs.
o Coordinated all GxP shipping activity as regulated by IATA/DOT
regulations.
o Perform detail chemical analysis on HPLC equipment. Document and report
results.
o Establish and maintain stability protocols and testing cycles for all
Inotek Corp APIs and drug products.
o Create qualification protocols and SOP for all wet chemistry and new
equipment used in the cGMP lab.
o Generated SOPs and controlled methods for all clinical samples and
chemicals used by QC and Biological labs.
o Generated CAPA (ST & LT) documentation for all discrepancies relating to
QC lab.
Chemical Specialist
o Perform a wide variety of chemical and physical tests using analytical
equipment and cGLP SOPs.
o Train new and current employees relative to cGLP and cGMP systems
according to FDA 210,211, & 820.
o Perform titrations, KF coulometric titrations, HPLC, UV, freeze point and
vapor pressure osmolarity, and Ph analysis.
Polaroid Corporation / Bedford, Ma (1978 - 1992)
Quality Systems/Product Engineering:
o Controlled the flow and analysis of all internal and external generated
quality signals and customer experience modeling.
o Presented performance information to various levels of management and
technical groups within Manufacturing, Research & Development, and
Worldwide Service.
o Initiated quality activities related to Polaroid's current film packaging
as well as all new marketing and packaging concepts.
o Instructor at Polaroid Statistical Institute.
Quality System Supervisor:
o Performed statistical data analysis and internal audits of all national
and international manufacturing facilities.
o Improved reporting and tracking systems for all Quality Engineering
Deviations, Engineering Changes and Reviewed Material (RMR).
o Established and monitored the budget for one salaried and three hourly
workers.
Engineer - Assembly/ Sub-Assembly:
o Generated product specifications, quality plans, and gauging requirements
to molding, metal stamping, packaging and pod manufacturing operations.
o Created in-process SPC system that resulted in $250K savings in rejected
components.
The Gillette Company/ Andover, Ma (1969 - 1978)
Engineer - Special Assignments:
o Conducted internal audits and compliance reviews of all quality systems
involved in incoming materials, in-process inspection, and final product
release of both Gillette and its contact fillers.
o Conduct external qualification audits of all contract fillers for
Gillette aerosol and non-aerosol products.
o Designed systems relating to product tractability and consumer complaint
information.
o Participated in a FDA audit of the Gillette Manufacturing Center and the
Right Guard AP product line.
o Designed Product Library system.
Engineer/Manufacturing:
o Created quality plans and standards for the manufacturing process of
Gillette's cosmetic and drug products.
o Implemented significant fill weight reduction program generating $180K
cost savings.
o Validated/qualified the filling processes; product transitions; and
analytical equipment.
Associate Engineer - Chemical:
o Designed quality plans, SOPs, and systems for all incoming chemical raw
materials, inter-mediate and finished chemical batches.
o Quality Engineering Rep to MRB for all non-conforming chemical materials.
o Conducted capability studies relating to the evaluation and acceptance of
chemical raw materials, finished batches, and aerosol and non-aerosol
finished products.
Chem. Tech:
o Performed wet chemistry analysis on raw materials or chemical batches.
Used UV, LC, titration, hydrometers, PH meter techniques and equipment.
EXPERIENCE: Customer Service Professional
Companies: Polaroid Corporation (1992-2001), Comcast (2002-2005)
o Continual growth from service engineer to technical service manager to
consumer service program manager.
o Implemented customer defect feedback system to highlight weakness in
product design or performance.
o Generated service plans covering product repair, parts lists and
diagrams, technical specifications, and FAQs.
o Created a cross functional team to generate photographic and product
features FAQs of all Polaroid films and cameras for the Polaroid website.
o Managed the personnel and professional development of a team of 8
photographic specialists.
o Conducted qualification audits of external repair vendor of Polaroid
commercial and consumer camera products.
o Coordinated worldwide service program strategy and support with European
and Asian service organizations supporting foreign markets of all new
consumer photographic products.
o Conducted technical and program presentations to various audiences
relating to product pr program specifics and progress.
o Trouble-shoot real time problems using Comcast product knowledge,
internal resources, and computer programs to resolve customer issues
during first call.
Well Developed Strengths:
o Team Dynamics - Manage various functions needed to launch a product
from concept to commercialization.
o Troubleshooting - Generate actions that resolve sporadic issues or
lower the level of chronic issues.
o Technical Skills - Chemistry, statistics, business theory, and
computer applications.
o Communications - Generated presentations, plans, or round-table
training sessions.
EDUCATION:
Boston State College - BS Chemistry
Suffolk University - MBA
A.S.Q.C. Quality Engineering Seminars; R.I.T. Photographic Seminars
Certified Quality Engineer (Past); ASQC Sr. Member (Past)
Polaroid Statistical Institute; Taguchi Experiments