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C. Dyan C

Head of Quality looking to refocus

Occupation:

Quality Manager

Location:

Corona, CA

Education Level:

Master

Will Relocate:

No

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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.

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SCHOOL MAJOR YEAR DEGREE

University of Texas at Arlington Biology, The focuses 2000 Master Degree
University of Texas at Arlington Microbiology 1996 Bachelor Degree
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Highlights:

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• 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
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