Ken Horner Email and Phone Number

I propose and write articles, stories and fiction for Catalyst Games, currently their BattleTech and Shadowrun lines. I've also done some work for Post Human Studios for Eclipse Phase.

Investigating customer complaints and implementing corrective actions as needed.

• Managed internal and external audits as head of auditing staff; liaised with external auditors.• Directed corporate change control system.• Evaluated compliance status for manufacturing ammonia in Morgantown, WV; identified several gaps in compliance and presented a recommendation to halt manufacturing until facility and processes were updated.• Liaised with FDA auditors during inspections.• Acted as validation coordinator for Illinois and California facilities; managed the change control process and served as sole back-up in Quality Control testing for new drug in development at the California facility.• Implemented an online ordering system after utilizing lean methodology to identify and address ordering system issues.

• Managed Quality Control laboratories for 11 sites across the country, including the training and management of all QC staff.• Authored and updated standard operating procedures; revised/ improved documentation and processes.• Launched a successful QC lab at a new site; decreased errors and improved cost savings by utilizing automated testing equipment; reduced testing time from 1 hour to 15 minutes.• Provided ongoing technical support (including after-hours and on-call support) and oversaw inventory management of equipment and supplies.

• Performed various analytical assays and testing of in-process and final product drugs for release.• Trained and led new members of the Quality Team. • Developed standard operating procedures, scheduled raw material testing, recorded exposure reports, maintained lab equipment, and informed management of any issues related to products or testing.• Designed a new combined laboratory, efficiently combining two labs and one office into a single area.• Utilized standard wet chemistry techniques, titrations, HPLC analysis, Gamma Spectrometer, Osmometer, and Electrophoresis Chamber; maintained radioactive dosage report for the department.• Ensured laboratory met and adhered to all safety and 5S organizational standards; prepared and disposed of all reagents in a timely fashion.• Served as member of the Hazardous Response Team.