Gordon Fralick

Experience

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  TwinLab | Natures Herbs

  Apr 1995 - Aug 2000

  Regulatory Manager - Head Chemist

  REGULATORY | FORMULATION MANAGER Aug 1998 – Oct 2000Established the first Regulatory Systems when DSHEA was implemented. Petitioned FDA for new supplement GMPs and Supplement Facts formats. Worked with QA/QC, Marketing, Production, and Raw Material Vendors to assure compliance with FDA regulations. Implemented National Nutritional Foods Association (NNFA) GMP’s by creating SOP’s, training personnel on procedures, and performing internal audits. Created raw material specifications and solved stability and formulation concerns. HEAD CHEMIST | LAB SAFETY OFFICER Nov 1995 – Aug 1998Provided chemical testing, training, and methods development. Performed safety training of lab personnel, conducted monthly seminars on HPLC for retail distributors and answered customer concerns. Provided technical support for customer services and R&D.MICROBIOLOGIST Apr 1995 – Nov 1995Performed traditional Pasteur microbial analysis for total plate counts, yeast and molds, coliforms, and fecal coliforms. Used ELIZA (Enzyme Linked Immunosorbent Assay) to test for pathogens. Show less

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  Pharmanex | NuSkin

  Oct 2000 - Sept 2003

  Manager Regulatory Affairs

  Managed the international regulatory systems and team. Led the Pharmanex GMP team in addressing concerns with the proposed GMPs and prepared for implementation. Developed and implemented systems to assure proper and timely registration of foods and supplements in more than 25 countries. Performed audits of registration documents.

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  Wasatch Product Development

  Sept 2003 - Jun 2004

  Quality Assurance Manager

  Created the quality systems to comply with cosmetic guidelines, food and supplement GMPs, OTC regulations, and prepared for TGA audit. Responsible for document control, creating and implementing SOPs, and training on all system. Oversaw testing and clearance of raw materials, in-process materials and finished products. Responsible for registering Wasatch with DEA, Utah Department of Agriculture, and the US EPA, and for registering foods, supplements, cosmetics, OTCs, and repellents.

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  USANA

  Jun 2004 - May 2005

  Manager of Regulatory Affairs

  Managed Regulatory Affairs Specialists in registering products, reviewing marketing material and all regulatory affairs in Asian markets for foods, dietary supplements and cosmetics. Worked with Business Development to open new markets for USANA; Malaysia, Thailand, Philippines and China

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  Agel

  May 2005 - Aug 2009

  Vice President of Regulatory Affairs and Quality Assurance

  Established and managed Regulatory and Quality Assurance departments from the company’s inception. Worked with third party vendors to assure quality and timely delivery of cosmetic and nutritional products.• Established Agel offices in domestic and international markets. • Worked with consultants, attorneys and government agencies to register products throughout the world. • Created and reviewed labels and claims. Reviewed all marketing literature and web material for compliance with government regulations. • Implemented quality systems, customer complaint system and adverse event reporting system. Created HACCP plans for Netherlands/ EU.• Worked with Orthodox Union and Islamic Food and Nutrition Council of America (IFANCA) to certify products Kosher and Halal. • Worked with laboratories for sports banned substances and nutritional analysis testing. Worked with laboratories and manufacturers to perform stability studies and ensure their successful completion. Show less

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  SoapBerry Solutions, LLC

  Sept 2009 - May 2012

  Founder and CEO

  SoapBerry SolutionsTM (SBS) was founded on an obsessive need for naturally cleaner homes and bodies, married with an intense desire to change the world. SBS is committed to providing high-quality natural soaps, using sustainable resources, and improving the lives of people throughout our sphere of doing business. SBS gives a portion of the proceeds from every sale to save lives with soap. • Created a new social enterprise based on natural home and personal cleansing products with a transaction based, philanthropic model. • Set up business entity, formulated products, established suppliers and shipping, produced packaging and marketing materials and formed a highly efficient team to bring innovative products to market through diverse sales channels. Show less

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  Nuriche, LLC

  Jun 2010 - Aug 2011

  Vice President of Operations

  Direct R&D, Quality Assurance and Product Development teams. Manage in-house manufacturing at Cedar City production facility.• Managed Manufacturing and Operations for all production.• Purchased, set up and trained Purchasing and Operations teams on Inventory Management System. • Lead Product Development Team, manage new products and resolve quality issues with existing products.• Created and implemented part numbering and Quality Control systems.• Register products and help open new markets. Show less

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  Asea

  Aug 2011 - May 2012

  Director of Compliance and Risk Management

  Direct Compliance Team. Manage ASEA Policies and Procedures.• Established a cross functional team to do a complete review and update of the Policies and Procedures.• Worked directly with Distributor Leadership to resolve high level concerns.• Worked with individual departments to determine company risks and potential solutions.

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  LifeVantage Corporation

  May 2012 - Feb 2022

  Direct Quality Assurance Team and all quality functions. Create and manage LifeVantage’s quality system, third party manufacturers and raw materials suppliers. Help manage the product development process for new products and new markets.• Created and implemented Quality Control systems from ground up.• Perform quality auditing for supplement and cosmetic manufacturing.• Perform quality auditing with raw material suppliers.• Created the quality manual and accompanying SOP’s, forms, diagrams and training.• Managed new product development through contract manufacturers Show less

  • Vice President of Quality Assurance and Regulatory Affairs

    Mar 2016 - Feb 2022

  • Director of Quality Assurance

    May 2012 - Mar 2016
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  Retired

  Mar 2022 - now

  Retired

  I have a degenerative Retinal Disease and have retired.