Quality Assurance Six Sigma
Resume:
K ADIRA HAGOS
919-***-**** K adi ********@****.***
*** ****** ****, ** ****, NC 27713
QUALIF ICATIONS
Excellent verbal and written communication skills for project presentations, developing
procedures, and document maintenance.
10+ years Administration computer skills including word processing, spreadsheet, database
management. Capable of developing and maintaining Access, MES, SAP, DOCUMENTUM,
TRACKWISE, LOTUS NOTES, and CERDAAC software databases.
Experienced in the regulatory industry requirements of ISO 9000, ISO 13485, MDD 93/42/EEC, FDA
and QSR requirements. Working knowledge of the integration between facility documentation and
manufacturing processes. Ability to implement documentation to meet business, user, and
regulatory requirements.
Excellent with prioritizing time to handle multiple assignments and to interact with product teams
to assure document control system is effective.
Highly motivated, detail oriented, possess excellent organization and problem solving skills.
Ability to assume ownership on projects and coordinate the efforts of others to complete goals.
Ability to develop and maintain a high performance work team culture focusing on the plant goals of
safety, quality, schedule and cost
PROFESSIONAL EXPERIENCE
Managed batch record review and product Quality Assurance release of all products
manufactured in the facility, and other BD facilities. Coordinator of the DC hold process and
interacted with DL QA Team to resolve QA related issues. Created, published and maintain
product certificates.
Worked closely with Quality and Operation Leadership to produce, maintained and publish
Quality Driven Metrics.
Provided product team support including customer complaint activities, statistical analysis,
validation support, inspection plans, metrology, quality metrics and report functions.
Coordinated all quality record process and ensures proper documentation and maintenance of
the files.
Administrator for Trackwise CAPA Management and assisted with the investigation of
Corrective/Preventive Actions (CAPA), notifications and customer complaints, providing solutions
where possible. Communicated customer feedback to Quality Systems group
Supported the development of team members’ knowledge and application of quality systems,
including engineering change control to provide consistent high performance.
Conducted internal audit to monitor and evaluate adherence to cGMP principles and Quality
Systems procedures.
Maintained updates to the Quality Manual and Quality Assurance Procedures.
Verified and inspected raw materials, finished product as per specifications
Verified control identification and traceability mark of product during all stages of production and
record.
Performed quality inspection for product per quality specifications.
Drafted technical process documents that fit the business needs, including creating, revising, and
assuring documents issued are in current formats.
EMPLOYMENT H ISTORY
BECTON DICKINSON AND COMPANY -MARCH 2000-JANUARY 2011 Durham, NC
27712
Quality Systems Technician-MARCH 2009-JANUARY 2011
Provide Central Quality professional support with development and improvement of
o
quality driven metrics.
Product Release Coordinator-NOVEMBER 2004- MARCH 2009
Managed batch record review and quality assurance release of all products.
o
Quality Associate-MARCH 2000- NOVEMBER 2004
Performed and verified quality inspection for raw materials and finished product.
o
EDUCATION
DURHAM TECHNICAL COMMUNITY COLLEGE Durham, NC 27703
Associates in Science- Expected Graduation June 2012
Bioworks- 2005
BECTON DICKINSON AND COMPANY UNIVERSITY Durham, NC
27712
Develop Your Career- 2006
SIX SIGMA-Statistics/MiniTab-2008
SIX SIGMA-YellowBelt-2010
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