Pharmaceutical Quality Control & QA Specialist

AMY HARTMAN

Grand Island, NY ***** · 716-***-****

************@*****.***

Twenty+ years experience in the pharmaceutical industry in a quality control/quality assurance environment specializing in the product stability, reserves, and qualified visual inspection programs. Excellent knowledge of USP, cGMPs, and good documentation/lab practices. EXPERIENCE

04/2009 – PRESENT

QUALITY CONTROL TECHNICIAN, FRESENIUS KABI USA

• Evaluated against standards by completing visual inspections

• Documented results and created reports using LIMS computer program

• Conducted data review and followed standard practices

• Safeguard customer requirements as well as quality standards by delivering support

• Data entry into ScienTek computer program

• 04/1999 – 04/2009

• QUALITY ASSURANCE TECHNICIAN, ASTELLAS

• Evaluated against standards by completing visual inspections

• Conducted data review and followed standard practices

• Safeguard customer requirements as well as quality standards by delivering support

• On-line AQL inspections

EDUCATION

06/1996

HIGH SCHOOL DIPLOMA, LEONARDO DAVINCI HIGHSCHOOL

SKILLS

• Excellent good documentation, record keeping

skills, and attention to detail

• Database knowledge: LIMS, ScienTek, Trackwise

and Documentum

• Microsoft Word, Excel, Outlook and PowerPoint

• Excellent written/verbal communication skills

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