Scott Jones Email & Phone Number

Westerville, Oh, Us

U.S. & International

• Coordinated supplier quality management, customer complaints, corrective actions, change control, process controls, SOPs and cGMPs (current Good Manufacturing Practices)• Completed filings for FDA FSMA, Device sites and state registrations• Conducted shared audits with drug and medical devise groups for common suppliers• Audited standards for quality systems and devices, e.g. FDA 21 CFR 117, 210, 211 and 820 and ISO 13485, Global Food Safety Initiative (SQF)• Conducted shared audits with drug and medical devise groups for common suppliers• Generated scorecards and reports using CARs, SCARs, COAs, and SPC• Developed production Failure Mode and Effect Analysis (FMEA) and used to address CAPA• Addressed customer complaints, using Kaizens to identify and implement quick wins• Implemented new sampling and inspection procedure to assure compliance to specification• Plant representative for interactions with customers as it relates to product or service quality• Used various business excellent tools to drive for true confirmed root causePlant Quality Manger, Sonoco Plastics – data collection, test methods, lab testing equipment– Addressed probation by customer and resumed full production in 4 weeksPackaging Engineer, Philips Health Systems – testing, and IQ/OQ/PQ validation of packages, equipment and linesPlant Quality Manager – plastic injection molding supplier, 3 shifts– Designed corrugated containers for finished products, audited suppliersQuality Systems – developed quality system for snack food companySupplier Auditor – used FDA Food Safety and Modernization Act (FSMA) guidelinesStatistical Evaluation – advanced analysis of data sets for qualification and validation purposesRegulatory Evaluation – conducted research to determine compliance on specific issuesQuality Systems Specialist – set up quality system for Food Company

Dublin, Oh

Responsible for developing, planning, prioritizing, providing oversight and managing a team for global supplier quality management programs.Work with Purchasing, Manufacturing, Supply Chain, R&D and Regulatory to implement a consistent global program for the global company supply base.

Global, Columbus, Ohio Area Based

Manage compliance of company sites, third-party manufacturers, suppliers and warehouses by conducting audits to Abbott, FDA (USA), CNCA (China), COKZ (Netherlands), EU (Europe), FSSAI (India), and CFIA (Canada) national regulations, ISO, SQF, FSSC, GFSI, and other applicable standards worldwide. Review Corrective and Preventative Actions (CAPA) plans to assure proper root cause identified and that plans are executed on timely basis. Perform assessments to support sites for detection and resolution of potential regulatory and compliance issues. Develop and implement risk based program for accepting GFSI third party audits of suppliers.Support redesign of division pest control processes, including establishing trending guidelines.Communicate findings to appropriate persons and assisted in development of CAPA plans.• Act as consultant to identify gaps in compliance and processes issues through review of FDA 483s and warning letters, pending regulations and internal and external audits• Designed and implemented risk based process to accept Global Food Safety Initiative certifying body audits• Completed 90% of audits at least 90 days ahead of schedule• Reduced travel expenses by over 33%• Oversaw division pest management program and coordinated with all sites to assure compliance to division Standard Operating Procedures (SOP) and local regulations• Co-led team developing warehouse selection and risk assessment tool

Columbus, Ohio Area

Held responsibility for assuring packaging aspects of new and modified packaging were in compliance with regulations. Served as QA lead on SimplePac and Hassia projects, responsible for developing quality programs and overseeing validation of all critical parameters; sourced statistical resources to complete project on time. Commercialized manufacturing of new packaging commodities on new and modified production lines.• Commercialized 4 new packages on five different filling lines.• Provided direction for continuous improvement by identification and resolution of packaging complaints.• Innovated packaging development process to improve speed to market while maintaining regulatory compliance. • Accountable for hiring and coaching a team of 4 professional and 2 contract associates