Quality Assurance Associate resume Westminster, CO - Hire IT People

QUALITY ASSURANCE ASSOCIATE:

Self-motivated and detail oriented quality professional with 3+ years experience in a GMP regulated environment. Comprehensive knowledge of cGMP and ISO regulations, auditing, and equipment validation.

CAREER HISTORY:

Confidential, Westminster, CO 09/2011 12/2011
Quality Assurance Documentation Specialist

Uploaded, routed, and formatted documents
Maintained electronic data base

Confidential, Boulder, CO 05/2007 06/2010
Quality Assurance Associate

Lead auditor of Agilent’s Vendor Qualification Program
Dispositioned incoming and retest of raw materials and components
Created, verified, and reconciled controlled labels
Point person for all QA related issues during 2nd shift
Reviewed batch records, New Equipment Acceptance Forms and analytical data packets
Compiled batch records and supporting data for clients on tight deadlines
Conducted daily compliance walkthroughs of QC, manufacturing floor, and the facility
Conducted temperature mapping on all Controlled Temperature Units (stability, quarantine, and release) according to ICH guidelines

Eppendorf 5 Prime, Boulder, CO 02/2002 10/2006

Formulation Associate

Formulated batch components for life science kits according to ISO9001:2000 standards
Managed raw materials inventory

Research Associate I

Collaborated on experimental Design and executed PCR experiments
Presented research data and results regularly
Wrote technical reports for kit reagents

Research Assistant III

Developed a monitoring system for controlled temperature units to ensure product and sample integrity
Oversaw that all new equipment was validated/calibrated prior to laboratory use
Initiated and controlled laboratory preventative maintenance work orders
Negotiated a 28% reduction on lab coat rental and laundering fees
Created and maintained cell bank for over 120 bacterial host/vector glycerol seed stock
Trained all new employees on laboratory safety

QUALIFICATIONS:

cGMP Training
Internal auditor (ISO9001:2000)
Document Control Routing
Process Deviation Report
Change Control
Emergency Response Team (ERT)
Corrective and Preventative Actions (CAPA)
Gel Electrophoresis
Standard/Real-time/Reverse Transcription PCR
Plasmid purification
Cell Transformation
Cell culture

COMPUTER SKILLS:

Calibration Manager
Microsoft Office Suite
SysPro (inventory tracking software)
BarTender™ (label making software)
Training Management System™ (EDMS)
Knowledge Tree™ (EDMS)
Dickson Temperature and Humidity software

EDUCATION:
Bachelor of Science in Chemistry

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Quality Assurance Associate Resume

Westminster, CO

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