I am applying for an upper management position within the Quality Department. • Experienced research and development. A scientist who successfully transferred knowledge, skills and experience in industry for new product development and processes in Pharmaceuticals and Nutritional Supplements. • More than fifteen years of managerial experience, which includes functioning with both domestic and global cross-cultural groups (92 countries). • Influencer leader focused on process improvement management, proactive instead of reactive. Responsible for the following functions; R&D, QUALITY LABS, DOCUMENT CONTROL, REGULATORY AND RISK, and COMPLIANCE. Expectations are clearly communicated. • Recruited, selected, oriented and trained employees for quality, production, laboratory, computer and Document Control functions. • Worked for and with Branded Pharmaceuticals, Nutritional Supplements industries and their contract manufacturers and suppliers. Brings R&D capabilities to each position having worked as a research scientist in the Pharma and Nutraceutical. • Given countless presentations, demonstrations and seminars, to all levels of management, employees, suppliers, and customers with which I am comfortable. • Hosted audits, including FDA, UL, other regulatory bodies, and customers. Audited suppliers, contract manufacturers, laboratories, internal departments, and third-party audits.

COMPANY	POSITION HELD	DATES WORKED
(Confidential)	Head Of Quality	9/2017 - Present
Paragon Laboratories (Nutritional Supplements)	Director Of Quality Contract	8/2016 - 10/2016
Par/Endo Pharmaceuticals (Generic Rx Pharmaceuticals)	Quality Specialist Consultant Symbol 183 \F "Symbol" Product Marketing Strategy	8/2015 - 8/2016
Herbalife International	Quality Compliance Manager	11/2010 - 4/2014
Herbalife Manufacturing (Otc, Cosmetics, Nutritional Supplements, Fortified Food)	Quality Assurance Manager	8/2009 - 11/2010
Micelle Laboratories (Otc, Nutritional Supplements, Fortified Food)	Quality Assurance Manager	12/2008 - 8/2009
Micro Imaging Technology Biotechnology	Laboratory Manager / Lead Laboratory Research Scientist	6/2003 - 7/2008
Southwestern Medical Center Department Of Neurology	Researcher Ra Ii (Molecular Geneticist)	10/2001 - 4/2003

SCHOOL	MAJOR	YEAR	DEGREE
University of Texas at Arlington	Biology, The focuses	2000	Master Degree
University of Texas at Arlington	Microbiology	1996	Bachelor Degree

Highlights:

GMP
Validation
Quality Assurance
Laboratory
Microbilogy
Quality Control
SOP
Quality Auditing
Quality Management
U.S. Food and Drug Administration (FDA)
QSM - Quality System Management
Quality System Compliance
Biotechnology
Chemistry
Auditing
Biochemsitry
Investigations
CAPA

• Complaints
• Documentation
• Audit
• Inventory
• ISO
• Manufacturing
• Procurement
• Quality
• Quality Assurance
• Quality Control

• American Society of Quality - Certified Quality Auditor (ASQ-CQA) • Lead Auditor Experience and Experience hosting regulatory and Customer Audits as the party responsible for the audit • SOP Development and Implementation • Process Improvement and Preventive Management • Auditing – Internal, Contract Manufactures and Suppliers • CAPA’s and Material Reviews • Documentation Control Management Experience • Pharmaceuticals (Solid Dose), OTCs (Sanitizers, Sunscreen and Pain Medication), Nutritional Supplements (Bars, Liquid, Powder, Tablets, and Capsules), Cosmetics (Haircare, Skincare and Oral Supplements), Food • 21 CFR Parts 110, 111, 210, 211, and 820 • ISO 14155 and 13485 • Familiarity with Medical Device Regulations in the US, Europe and Canada • Laboratory, Quality Compliance and Quality Assurance Management • cGMPs, SOPs, state, local and federal regulations, in addition to customer specific requirements • Experience with Sterile Manufacturing regulation and requirement for OTC’s