Quality Assurance Project Management

Objective

To obtain a position where my skills will benefit an organization to achieve their goals.

Education

B.S. in Operations Management and Information Systems, National Louis University

Employment History

BAXTER HEALTHCARE - Round Lake, IL

(Hiregenics)

Regulatory Affairs Associate, 2013-2015

Assisted Baxter representatives in countries all over the world in registering Baxter products with their respective Ministry of Health

Lead in the creation and maintenance of a master database to track where thousands of products were registered in several hundred countries

Coordinated with different divisions of Baxter in order to request or produce deliverables that would be sent to regulatory agencies

Solely responsible for creating dossier that would contain relevant ISO certificates, technical documents and legalized statements in order to satisfy the requirements of a specific government agency

Organize labeling changes to present them to regulatory agencies in a clear and coherent manner

BAXTER HEALTHCARE - Round Lake, IL

(Kelly Services)

Quality Assurance, 2009

Used Excel to cite world regulations that apply to Baxter and its products

Used an Excel spreadsheet to map out Baxter’s Corporate Quality manual and where it applies to the world regulations

Copied all the regulations from the applicable countries drug laws that Baxter must follow into a master document

Volunteer Work

BIG BROTHERERS BIG SISTERS OF AMERICA – Dekalb, IL

Volunteer, 2011 to 2012

Skills

Notary Public in the State of Illinois Expert in Microsoft Excel

Proficient in Windows XP/Vista/7/8/10 Proficient in Macintosh OS

Review of Technical Documents Review of BoMs / DHF files

Experience with International Standards Organizations Access 2013

Experience with label redlines and history files Technical Troubleshooting

Computer Hardware configurations and installs Project Management

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