Charles Ashe Email and Phone Number

Overall responsibility for Quality Assurance and Quality Control for the largest manufacturer of liquid antacids in the world.

Technical and regulatory consultant for sulfur chemical / dietary supplement manufacturer.

 Responsible for company overall Quality Assurance and cGMP compliance for manufacture and packaging of Active Pharmaceutical Ingredient (API) Dimethyl Sulfoxide (USP) product.  Audit all suppliers (vendors) to insure adherence to cGMP’s or ISO 9001 standards as applicable. Provide regulatory / technical / documentation support for customers and Gaylord marketing personnel regarding DMSO USP and all other products. Facilitate and manage customer audits of Gaylord’s cGMP and ISO 9001:2008 Quality Management Systems. (Usually 6-10 audits per year) Lead all CAPA investigations and report findings to customers and make notifications. Facilitate and manage regulatory (FDA) audits of Gaylord’s cGMP manufacturing process. Manage all facets of Quality Assurance / Analytical laboratories including product research and development. Maintain and update all MSDS and SDS Sheets for products.

 Maintain all analytical instrumentation required for complete product analysis and research and development efforts. Assure that analytical tests are standardized, properly performed, and conducted at a frequency which insures that the manufacturing and project functions are operating within safety and quality parameters for both Dimethyl Sulfide (DMS) and Dimethyl Sulfoxide (DMSO) manufacturing units. Review and approve all product Quality Specifications and customer quality / analytical requirements. Manage daily activities of QA/QC Chemists and lab technicians. Develop, write, and maintain all cGMP Quality System procedures and protocols for Pharmaceutical Dimethyl Sulfoxide (USP) product. Certify and maintain training for all personnel performing Quality Assurance testing including testing of products manufactured in cGMP production unit. Troubleshoot manufacturing processes during product quality excursions. Maintain ISO 9001: 2008 Quality Management System and insure adequate training for all personnel. Develop and perform R&D projects and provide analytical support to all other R&D projects. Responsible for Chemical Hygiene and Chemical Handling training for all plant personnel. Investigate and remediate all customer reported Quality issues. Provide customers with regulatory and quality related documents and reporting practices.

 Performed all routine product Quality analyses. Implemented Customer Quality Reporting System Implemented ISO 9001:2000 Quality System in labs Responsible for packaging and shipping customer samples of all products and grades. Developed and implemented any new or modified analytical methods. Developed and or documented all written laboratory analytical procedures. Responsible for training all operations personnel on current and any new analytical instrumentation.

 Operator for Dimethyl Sulfide and Dimethyl Sulfoxide production units. This job function included three (3) years of process training with documented certification testing as per OSHA Process Safety Management (PSM) requirements.  Supported in-process quality analysis of both DMS and DMSO production units including process troubleshooting. Supported in-situ presulfiding of refinery catalysts for several major petrochemical refineries around the US. Experienced in use of Honeywell DCS 3000 Plant Distributive Control System.

 Performed various NPDES and wastewater analyses for all discharge points for Stennis Space Center.  Developed unique analytical for As and Se eliminating potentially hazardous reagents. Helped develop and implement Atomic Absorption metals analysis methods in support of the Advanced Solid Rocket Motor (ASRM) project.

Responsible for the operation and environmental compliance of an Industrial Waste Treatment lab and developing treatment schemes for various metal plating solutions used in the manufacture of 155 mm artillery rounds.Worked in Surface Treatment lab performing testing on the various steel and aluminum plating solutions and recommending additions / changes to the systems.Performed various NPDES analysis for all discharge points for Industrial Waste Treatment plant / Sanitary Waste treatment plant.Responsibilities included troubleshooting and providing analytical expertise and support for operational performance of metal plate waste treatment plant.Developed and validated in-house analytical methods and developed relevant analytical procedures.