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Engineer Customer Service

Location:
Port Charlotte, FL, 33948
Posted:
September 24, 2010

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Resume:

Edward J. Dacey Jr.

***** ***** ***, **** *********, Fl 33948

978-***-****

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



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