Earl Quiller

Quality Control Laboratory Manager (Analytical Chemistry & Microbiology) @Elanco

Develop, Mentor and Manage 31 direct reports (Chemists, Biologists, Lab Analysts and EM Technicians) in a state of the art biotechnology facility providing 24/7 continuous support during the manufacture of a sterile injectable parenteral product. • Improved Quality systems for Microbiological and Analytical testing to ensure that raw materials, in-process materials, active pharmaceutical ingredients, finished products and stability studies meet defined quality criteria in accordance with approved standard operating procedures. • Provides technical support for continuous improvement in laboratory operations. Including support for method development, method improvement, method validation and technology transfers. • Implemented continuous improvement initiatives and the continued training and development of all team members in the areas of safety, cGMP compliance, and on -The -job requirements. • Review and approve SOPs, analytical data, and corrective action reports. • Assess any non-conformance/out – of-specification (OOS) results, determines impact on product, and ensures timely resolution or corrective action. • Provide oversight for analytical equipment and computer system qualification and validation activities. • Facilitate/ participate in quality audits as necessary to assure effectiveness of the QC Laboratory Quality system. • Manages $4M Laboratory Budget • Coordinated EU/FDA inspections and responses to FDA-483 observations.