Quality Bio-Pharmaceutical professional with ISO/GMP/TQM experience and strong data management in inventory control & distribution. Ability to design, develop and improve process systems. Bi-lingual in Spanish and English. Additional skills and knowledge include: Package & Labeling Design; Documentation Editing; Contract Facility Audits; Statistical Analysis; Return Destruction Processing; Charting Trending; Contract Vender Management; Foreign Language Translations; Quality Control

COMPANY	POSITION HELD	DATES WORKED
Remec Broadband Wireless	documentation coordinator	10/2009 - 10/2011
Photothera	Documentation Specialist II	5/2008 - 10/2008
Nanogen, Inc.	Quality Inspector/Documentation	7/2007 - 5/2008
Ligand Pharmaceuticals Inc	Senior Clinical Supply Coordinator	2/1997 - 2/2007

SCHOOL	MAJOR	YEAR	DEGREE
associated technical college	telecommunications	1984	Trade School Degree

Highlights:

Companies I like:

Open to all Medical device and bio pharmaceutical companies

P&L responsibilities
Presentation
Ecommerce Strategy and digital marketing channels optimization - SEO, SEM, email, affiliates - for high-profile accounts.
Technology Solutions
Sales Support
Software Implementation
Requirements Analysis & Specification
Leadership

• Quality Assurance
• Documentation Specialist
• Inspector
• Audits
• Calibration
• GMP
• ISO
• CAPA
• Change Control

·Responsible for performing a variety of activities to ensure compliance with applicable regulatory requirements by handling complaints, data and documentation reviews and analysis. ·Wrote and revised standard operation procedures and related complaint documents. ·Supported the QA system by participating in internal audits, batch record review for release of product, and supported the document control system. ·Coordinated the investigation, corrective and preventative action and closure of complaints.