Quality Assurance Technician
Resume:
Sheila Olewine
Elkton, MD **921
410-***-**** (H)
302-***-**** (C)
abm9qv@r.postjobfree.com
Executive Summary:
? Self-starting, goal-oriented strategist whose
confidence, perseverance and vision promote success.
Experience:
W.L. Gore and Associates Elkton, MD
Quality Laboratory Associate 4/09 to Present
? Perform physical property tests to insure that product meets required
specifications. Testing includes: chemical penetration, colorfastness,
spectrophotometer analysis, flammability, instron strength and
penetration analysis and other property testing. Also, as a certified
shade evaluator performs visual shade evaluation to insure products are
within established boundaries. Review all vendors Certificate of
Analysis for compliance to required specifications. Contact vendors if
any discrepancies are discovered. Prepared monthly quality reports for
large vendors. These reports review vendor performance to established
goals. Leading a project to integrate laboratory instrumentation with
the laboratory information management system. This effort will allow the
direct output of data into the information system. This will eliminate
entry errors and the need for retests due to these errors.
W. L. Gore and Associates Elkton, MD
Vendor Quality Engineer 8/05 to 4/09
? Contributed to company success by working with vendors to improve
their systems and processes so that they can meet product requirements.
This includes: the facilitation of vendor incidents, conducting vendor
audits and partnering with vendors on quality improvement plans.
Additionally, monthly quality reports are prepared for larger vendors.
These reports provide vendors with information concerning their
performance to established goals (scrap rate, number of vendor incidents,
DOT and RGAs as a percent of the total spend). Also, as certified ISO
Lead Auditor perform both internal and external audits.
W. L. Gore and Associates Elkton, MD
Quality Assurance Partner 3/02 to 8/05
? Partnered with a business unit and owned the quality for that
business unit. Focused on process yield enhancement, product development
and design controls activities, and systems enhancement including
software implementation and validation. Developed policies and
procedures, which affect operational compliance status.
W. L. Gore and Associates Elkton, MD
Quality Laboratory Leader 3/95 to 3/02
? Set direction for the laboratory and ensure that business needs are
met and required services performed. This includes: identify critical
lab constraints and find creative and innovative solutions, champion
development of new and improved test methods, identify and nurture
leadership and sponsorship skills in associates, and maintain a highly
skilled, trained, flexible workforce
Terumo Medical Corporation Elkton, MD
Quality Assurance Controller 3/93 to 3/95
? Direct control of implementation and maintenance of GNP's for a
production department. Furnished monthly reports to plant management
concerning deviations from product standards and recommendation as to
improvements, which needed to be addressed. Applied trend analysis data
to write product standards which were both meaningful and user friendly.
Terumo Medical Corporation Elkton, MD
Senior Microbiologist 6/89 to 3/93
? Reviewed all sterilization documentation and acted as a liaison
between the company and the contract sterilizers to rectify
accountability and sterilization deviations. Responsible for the
supervision of junior staff members and training for new hires.
Performance of environmental monitoring of the production site and
performance of the Limulsus Amebocyte Test as well as Total Aerobic
Bioburden Testing to assure a sanitary work environment. Also worked with
production personnel to resolve any deficiencies which were discovered as
a result of testing.
Microbiological Associates Bethesda, MD
Program Coordinator/Contracts Assistant 2/87 to 6/89
? Coordination of the following: costing of commercial and
governmental studies, monitor labor projections for contracts; act as a
liaison between Quality Assurance and Department Heads. Key project
include coordinating and assisting FDA site visits and maintaining the
test article inventory.
Microbiological Associates Bethesda, MD
Laboratory Supervisor 2/86 to 2/87
? Supervise the administrative and technical aspects of the Ames
Mutagenicity Assay including: data analysis, final report preparation,
training new technicians, ordering supplies, and preparing weekly
schedule.
Microbiological Associates Rockville, MD
Senior Ames Technician/Group Leader 6/82 to 2/86
? Independently perform and manage technical and administrate aspects
of the Ames Mutagenicity Assay. Other job responsibilities include: the
preparation of appropriate media and reagents, the safe handling of
hazardous substances, and accurate record keeping.
Laboratory Technician E. G. & G. Mason Research Institute
Rockville, Maryland 7/80 to 6/82
? Responsible for the performance of the Ames Mutagenicity Assay. Also
responsible for the maintenance, calibration and operation of laboratory
equipment.
Madison Industries Old Bridge, NJ
Laboratory Technician 6/79 to 6/80
? Responsible for analyzing materials, in-process samples and outgoing
products to assure the products were within prescribed tolerances.
Education: West Virginia Wesleyan College Buckhannon, WV
Bachelor of Science
References: Available upon request
Contact this candidate