- Manage QC Laboratory: standardized test methods; developed a database to digitize, archive, calculate data, and print certificates of analysis; implemented a program to statistically trend all QC, raw material, and manufacturing data; develop, write, and issue Standard Operating Procedures (SOPs), forms, and records; train employees.- Manage ISO 9001 Quality Management System: company's ISO 9001 Management Representative. Responsibilities include Document Control Coordinator, managing Corrective Action and Preventive Action program, managing Internal Quality Audit Program, Internal Quality Auditor, participate in customer, supplier, and quality registrar audits.Accomplishment: Over the past 5 years; quality registrar, UL DQS, audits have resulted in 2 findings or "Action Requests" and experienced a 75% reduction in customer complaints.- Manage Technical Service working with existing & new customers to develop new products; improve existing products; and assist in testing products for industry specific tests, such as those required for automotive PPAP or aerospace AMS specifications.Accomplishment: Over past 5 years have had 5+ new products approved bringing in >$2 million in 2015 and >$3 million in 2016.- Production Support: Support daily manufacturing activities by managing 50+ formulations, 24 raw material vendors, and 5 calibration vendors. Schedule & document preventive maintenance, and performing a "starting" inspection for all pelletized free flow products.- Manage Regulatory Affairs program. Includes maintaining facility's state issued Permit to Operate, communicating with state, and assisting customers in certifying products to European & USA regulations. Generate, maintain, and distribute company's Safety Data Sheets (SDS) for finished products and raw materials.

Managed activities of 10-15 people, scheduled orders for production, checked to ensure raw materials were in-stock and approved for use so that daily production goals were met. Successfully developed Excel spreadsheets to (1) manage facility's electricity usage with goal to keep cost as low as possible and (2) to correlate and track processing conditions with production yield and amount of scrap produced while manufacturing pelletized free flow products with the goal to improve yield while decreasing scrap.

Developed and wrote procedures for ISO 9002:1994 certification that was attained in November 1997, scheduled orders for production, and generated production traveler, or Mix sheet, for jobs scheduled for production. Managed company's Continuing Improvement Program.

- Worked in cGMP regulated Microbiology Lab isolating and identifying bacterial and mold contaminants found during cGMP required environmental monitoring of sterile and dust free production areas.- Assisted in setting up, performing, and quantifying results of sterile fill trials as part of FDA's cGMP required qualification of sterile filling rooms.- Accomlishment: Designed and carried out a study of the effectiveness of ultraviolet cabinets and pass-through boxes used to sanitize safety glasses and pass processing paperwork into sterile manufacturing area. Findings resulted in increasing the number of UV lights in both cabinets and pass-through boxes as well as suggesting a minimum exposure time for items being sanitized in the UV light.

- Performed cGMP required environmental monitoring of sterile and dust free production areas as well as product manipulations to ensure proper equipment sterilization and operator technique used.- Tested filter integrity for sterile manufacturing, including ceiling HEPA filters and cartridge filters.

In the Internal Environmental Control Group that tested integrity of facility's filters - both sterile suite's HEPA filters and manufacturing's cartridge filters.