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· Tracked,
pursued, investigated and took corrective action for hundreds of
computerized systems for facilities in the US and Europe. Brought several
ERES projects to a successful conclusion.
·
Successfully validated
Corrective/Preventive Action, Audit, and NCMR (CATs web) dBase
software.
·
Managed, planned,
strategized, created
procedures, and executed facility validation to a
successful FDA approval for a medium (41,000ft2) electronics
medical device company.
·
Provided all product
transfer activities, including DOE’s, product stability,
validations, and industrial statistics, to a successful
510k approval at an in-vitro-diagnostics startup company.
·
Created Access - SQL
dBase system for easy retrieval/entry, flagging, and trending on
return products and product failures.
·
Invented and assisted in
patents for improvements of
techniques and devices in environmental monitoring.
·
Expanded company Access
based MRP system using VBA.
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Fully trained
departments on statistics, trending, and proper data acquisition and
interpretation.
·
Trained
departments on use of Office
applications, Windows, email systems and more.
·
Managed
5+ people at a time in product transfer, metrology, warehousing, validations
and other.
·
Expanded and managed
metrology, QE, purchasing, and Info.
Systems simultaneously.
·
Investigated and found
source & reason of
microbiological contamination saving company 2 weeks of quarantine, 40K
units of waste, and $100K+
·
Solved numerous Novell
based network and LIMS system breakdowns.
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Investigated and solved
source of amino acid solution filling process and filling line variance
preventing waste, creating rapid corrective action, and saving $150K.
·
Solved
injection molding, blow molding, and film
delamination
problems with engineers and mechanics.
·
Was a contributing Quality
Engineering representative board member in the development of
new silicone barrier dual chamber oxygen sensitive parenteral bag.
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