Ron Hare

• Conduct Dietary Supplement, Food, OTC, Warehouse/Distribution, and Cosmetic GMP audits as an Independent Contractor for UL, NSF, GRMA, and SSCI • Audit Scopes include NSF 173, GRMA NSF/ANSI 455-2 Dietary Supplements and 455-3 Cosmetics, FDA 21 CFR 111, 117, 121, and 211, HACCP, and ISO 22716 • Completed over 250 audits in the United States, Canada, Mexico, and Australia • Manage onsite and virtual initial, annual surveillance, and verification audits for existing and new customers including determining audit dates, audit preparation, scheduling travel and accommodations, performing opening/closing meetings, audit and non-conformance reporting, as applicable, and approval/rejection of Corrective Actions

Lead Auditor – Manage and perform on-site audits of contract manufacturers (CMOs), raw material suppliers and distribution centers, ensuring compliance with current Good Manufacturing Practices (21 CFR 110, 111, and 117), and Isagenix. Conduct Master Manufacturing Record (MMR), Batch Record (BR), and Packaging Record auditing for 80+ products. Qualify potential and existing (25+) CMOs, Suppliers, and DCs. Approval of food and dietary supplement labels, following FDA 21 CFR 101, Health Canada, TGA, and EU Annex Regulations. Create, develop and implement Standard Operating Procedures (SOPs). Create training presentations and conduct training on new procedures, as well as existing procedures and practices.

Managed QA department of 21 direct reports and maintained quality oversight of all operations following 21 CFR Part 111. Developed and implemented in-process AQL finished product sampling plan with no product or packaging components loss. Performed internal audits, including process audits and monthly sanitation audits. Established metal detection program. Spearheaded Deviation Committee, set up tracking and trending system for Deviation review and application of CAPAs, if necessitated. Reviewed, approved and released Batch Records, production documentation, quality control release records, Certificates of Analysis and/or Certificates of Conformance. Created and Implemented Primary Packaging Materials Specifications and Qualifications. Developed Packaging Masters. Investigated and reported on Customer Complaints. Trained and mentored quality unit. Managed all QAU equipment including purchasing, maintenance and annual/quarterly calibrations.

Sales and Services, Residential Real Estate Small Business Ownership Realty Consultant, Property Manager, Investor Manage all facets of Hare Realty, LLC principal and secondary business enterprises. Residential Services including consulting, buying, selling and renting residential homes as buyer's/seller's agent. Property Management services including marketing, renting, communications, collections, maintenance, and inspections. Investment services including procuring, renovating, marketing, and negotiating the sell or rent of properties. Establish short- and long-term company direction, identifying new business opportunities. Perform continual financial analysis of company's assets/liabilities, cash flow, and budget forecasts, while managing accounts payable. Established and cultivated relationships with vendors and contractors. Increased productivity in sales, volume and listings Y/Y in residential services since inception of LLC in 2006. Launched secondary business of Property Management Services with an increase in inventory Y/Y. Implemented marketing strategies, while streamlining overall marketing operations, supplying additional leads and forging name recognition of area expertise. Fronted the acquisition of numerous residential properties, directed all renovations, strategically marketed and advertised, and rented/sold, substantially increasing company revenue.

Global bioresource center that provides authentication, preservation and development of biological products Biological Materials Manager Responsible for the operational implementation and management of biological materials management services related to managing client materials. Provided materials management services to clients either at the client's facility or at an ATCC satellite facility. Collaborated with clients to develop an overall program for their materials, assisted in securing facilities where needed, and developed the resources to provide the services. Championed logistics of satellite facility enabling cost reduction with more efficient turn-around times. Spearheaded inventory management procedures. Strategically enhanced inventory capabilities, increasing material capacity, and resulting in supplementary revenue.

Managed the Novavax Quality Assurance Unit and maintained quality oversight of all operations with contract facilities. Created, reviewed and maintained Standard Operating Procedures (SOPs), Batch Records, production documentation, quality control release records, material specifications, safety testing protocols, and equipment use logs. Approved validation documents to ensure compliance with validation master plans, policies, and guidelines. Met production schedules through active coordination with team members and management. Assisted in developing departmental goals and objectives. Championed development of pilot manufacturing facility Instituted electronic tracking system for SOPs, deviations, investigations, and instrument calibration. Trained, mentored, and supervised quality unit. Developed and implemented quality system SOPs and monitoring procedures to ensure compliance with cGMP (current Good Manufacturing Practices) and cGLP (current Good Laboratory Practices) requirements. Enforced all established CAPA (Corrective and Preventative Action) procedures and handled deviations Conducted external audits ensuring vendor compliance and Conducted and created documents for all internal and external audits. Instituted inventory and procurement processes. Performed or assisted in training of all personnel

Ensured cGMP and GLP compliance. Wrote, modified/revised and updated SOPs and forms. Document and inventory control. Instituted Novavax procedures in conjunction with King Pharmaceutical's procedures to launch scale-up process of HPV vaccine. Reviewed and approved all HPV vaccine manufacturing documents, including SOPs, batch records, document change requests, material specifications, and deviations. Established process flow for incoming materials and provided inventory management. Determined the appropriate disposition (quarantine, approval, rejection) of incoming production and non-production materials and components

Biopharmaceutical company that creates novel vaccines to address infectious diseases; Performed environmental monitoring of cleanrooms, including viable and nonviable airborne and viable surface particulates, and cleaning validation Provided real-time environmental monitoring, reducing vaccine production/manufacturing loss. Conducted bioburden analysis of water system. Isolated and identified all bacterial contaminants. Performed functionality tests on various mediums. Trained personnel in gowning techniques and performed validation testing. Designed and implemented receiving processes. Received, quarantined and approved/rejected all production components and materials, including approval/rejection of Cert. of Analysis/Conformance. Instigated cost reduction strategies for production and non-production materials and components. Optimized material and process flows by designing new floor layouts.

Extract and calculate phenols, oil, and grease from incoming customer samples using EPA standards and regulations. Accept, log-in, label, test, and dispose of relinquished samples from customers and field techs. Develop and implement innovative organizational needs for sample storage and disposal.