Quality Assurance Control

SHARON BELLAMY

P. O. Box *****

Indianapolis, IN 46208 *********@*********.*** 317-***-****

QUALITY ASSURANCE ANALYST

Data Analysis ~ Workflow Assessment ~ On-Site Support ~ User Documentation ~ Test Plans and Standards Test Cases and

Scripts ~ Functionality Testing ~ Technical Writing

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Resourceful and dynamic technical professional with six years of software quality/functionality testing expertise, coupled

with SQL statement knowledge. Skilled product consultant; consistently identified by clients as critical player in the

success of the project. Recognized as a creative thinker by team members and senior management; willing to exhaust all

avenues to deliver a highly functional product to the client in a timely fashion. Well versed in the areas of organization,

workflow, and time management.

Eli Lilly Corporation – Indianapolis, IN

Pharmaceutical Industry leader in Insulin Injection

Quality Technician

October 2002 – August 2010

Revise visual inspection methods, standard operating procedures and validate lab test systems ~ IQ/OQ/PQ ~ Experience

with 21 CFR 820.11 regulations~ Direct and train quality laboratory technicians in new testing methodologies and test

systems ~ Document product defects to initiate corrective actions ~ Technical writer for analytical investigation

reports ~ Analyze large amounts of data, recognize patterns and trends ~ Prepare and present monthly metrics for senior

management ~ Working knowledge of statistical controls and sampling plan methods ~ Clinical trial testing ~

Inspect/test product in various stages of production ~ Ensure compliance with QA/QC initiatives ~ Collaborate

with quality engineer, quality representative and contract manufacturers to determine cause of recurring defects

~ Working knowledge of Change control, FMEA, CAPA system and FDA regulation ~ Layout inspection and

interpretation of engineering drawings and blueprints ~ Create test plans, develop/execute test cases, and test core

module functionality ~ Initiate quality assurance strategies, which include improved testing procedures ~ Working

knowledge of SDLC methodology ~ Knowledge of functional-level testing, both white box and black box testing

Notable Accomplishments

• Designed and implemented test scenarios and test scripts used in end-to-end testing

• Subject matter expert for user acceptance/functional/regression tester and reviewer for all new software

applications test methods

• Revise standard operating procedures

• Establish a presence as the primary resource for all new software application training

• Visual/functional inspection instructor to European affiliates, and contract manufacturers

Eli Lilly Corporation – Indianapolis, IN

Pharmaceutical Industry leader in Insulin Injection

Material Operator

March 2000- October 2002

Sharon Bellamy

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Dispense raw materials to ensure on-time service to production areas ~ Monthly inspections audits on logbooks,

laboratories, and warehouse with senior management and Quality Representative ~ Quality Control SME (Subject

Mater Expert) ~ Monthly procedure review team member ~ Employee mentor and instructor

Notable Accomplishments

• Inventory SME – Purchase and forecast supplies for manufacturing departments.

• Revise standard operating procedures and processes.

• Present quality and safety recommendations during monthly departmental meetings.

AreoFab Corporation, Indianapolis, IN

Aerospace Fabrication Industry

Quality Control Inspector

February 1998 – March 2000

Inspect in-coming, in-process, and final assembles ~ Create programs to inspect parts and fixtures on the

Coordinate Measuring Machine ~ Interpretation of engineering drawings and blueprints ~ Layout of aircraft

engine tubing and components for major aircraft companies and fixtures utilizing the application of GD&T

language ~ Working knowledge of inspection tools: calipers, micrometers, optical comparators, gage pins,

blocks, square, sine bar, and height gages

Notable Accomplishments

• Creator for all part and fixture programs on co-ordinate measuring machine

EDUCATION

B.S., Computer Information Systems, University of Indianapolis ~ Indianapolis, IN ~ 2008

A.A.S., Electronic Engineering, ITT Technical Institute ~ Indianapolis, IN ~ 1992

Certifications

Project Management, IUPUI ~ Indianapolis, IN ~ 2009

Training/Courses

Risk Management, FMEA, QSR, ISO/QS9000, FDA Regulatory Affairs, Gage R&R, GD&T, cGMP, GLP, CAPA, Change

Management, CSQA, HTML, SQL, PLSQL, Visual Basic, Information Systems, Disaster and Recovery, ERP, SDLC,

System Analysis and Design, Cisco Networking, A+, Networking, and JMP.

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