Katherine Gilson Email and Phone Number

Leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

Oleochemical Manufacturer – GMP, HACCP, Responsible Care, SQF, OU, ISO 9001 & 14001 Certified– P&G Contract Personal Care Manufacturer• Facilitate resolution of SOP and documentation noncompliance for up to 17 products per day, each with 50 quality checks at various intervals, to ensure products follow contracted specifications; resulting in prevention of off-quality product from shipping, leading to decreased waste, saving recall and reproduction costs, and team confidence.• Establish… Show more Oleochemical Manufacturer – GMP, HACCP, Responsible Care, SQF, OU, ISO 9001 & 14001 Certified– P&G Contract Personal Care Manufacturer• Facilitate resolution of SOP and documentation noncompliance for up to 17 products per day, each with 50 quality checks at various intervals, to ensure products follow contracted specifications; resulting in prevention of off-quality product from shipping, leading to decreased waste, saving recall and reproduction costs, and team confidence.• Establish rapport with team members (including managers, supervisors and operators), which promotes a cooperative, collaborative atmosphere for sustained quality control.• Investigate out of specification and noncompliance events, contributing factors, and root causes to improve product quality and remove the possibility of repeat incidents (CAPA investigation), and save production costs.• Perform Gemba walks to Identify daily safety and quality issues and recommend permanent solutions to prevent safety incidents. Show less

Government Contracting: USEPA NERL Contract, Cincinnati, OH– Q.A. Officer 2004-2016Contract held by three different companies: SoBran 2004-2005, UES 2005-2006, and CSS-Dynamac 2006-2016• Confirmed procedures reflected actual practices, and met requirements, resulting in accurate records, compliance to standards, reproducibility of results.• Brought continuity to the contract by collaborating and instigating redesign of Standard Operating Procedure (SOP) formats and numbering… Show more Government Contracting: USEPA NERL Contract, Cincinnati, OH– Q.A. Officer 2004-2016Contract held by three different companies: SoBran 2004-2005, UES 2005-2006, and CSS-Dynamac 2006-2016• Confirmed procedures reflected actual practices, and met requirements, resulting in accurate records, compliance to standards, reproducibility of results.• Brought continuity to the contract by collaborating and instigating redesign of Standard Operating Procedure (SOP) formats and numbering conventions incorporating input and buy in from 10 people, from various disciplines with 150 SOPs, to provide procedural consistency; resulted in more productive SOP development, archival, availability, and tracking continuity.• Forged solid internal/external relationships with researchers and management; initiated and tracked follow-up on customer approval status and grew positive customer feedback for quality document approval.• Formulated a process to standardize equipment maintenance and calibration, improving traceability and timeliness of maintenance and troubleshooting, and associated records.• Performed five to fifteen audits of various disciplines per year. Each with simultaneous and competing deadlines.• Quality Assurance Manager- PHILIS USEPA ERLN Contract– CSS-Dynamac 2009-2010○ Performed simultaneously with NERL contract position.○ Developed Quality Management Plan for the successful PHILIS contract proposal.○ Initiated mobile laboratories QA program to follow regulations and gain accreditation. Show less

Government Contracting: USEPA NERL Contract, Cincinnati, OH– Q.A. Officer 2004-2016Contract held by three different companies: SoBran 2004-2005, UES 2005-2006, and CSS-Dynamac 2006-2016• Confirmed procedures reflected actual practices, and met requirements, resulting in accurate records, compliance to standards, reproducibility of results.• Brought continuity to the contract by collaborating and instigating redesign of Standard Operating Procedure (SOP) formats and numbering… Show more Government Contracting: USEPA NERL Contract, Cincinnati, OH– Q.A. Officer 2004-2016Contract held by three different companies: SoBran 2004-2005, UES 2005-2006, and CSS-Dynamac 2006-2016• Confirmed procedures reflected actual practices, and met requirements, resulting in accurate records, compliance to standards, reproducibility of results.• Brought continuity to the contract by collaborating and instigating redesign of Standard Operating Procedure (SOP) formats and numbering conventions incorporating input and buy in from 10 people, from various disciplines with 150 SOPs, to provide procedural consistency; resulted in more productive SOP development, archival, availability, and tracking continuity.• Forged solid internal/external relationships with researchers and management; initiated and tracked follow-up on customer approval status and grew positive customer feedback for quality document approval.• Formulated a process to standardize equipment maintenance and calibration, improving traceability and timeliness of maintenance and troubleshooting, and associated records.• Performed five to fifteen audits of various disciplines per year. Each with simultaneous and competing deadlines. Show less