November 14 2019 OMB Meeting Materials

AOAC OMB MEETING MATERIALS

109

Eurofins Central Analytical Laboratories 2219 Lakeshore Drive, Suite 500, New Orleans, LA 70122 (504) 297-3400 Toll Free: (866) 388-3400 Fax: (504) 297-3410

from encompassing two Seed Quality Technology (SQT) teams to inclusion of multi- site SQT, Gene Assessment and Molecular Analysis and Vector Quality Control teams, Bangalore Product Support, Sequencing, Cloning, Transcript Profiling and Protein Analytics Immunoassay team, bringing ISO QMS team membership from 30 to approximately 150 personnel in two years. Developed BIO Excellence Through Stewardship (ETS) compliant QMS for the Biotechnology organization and rolled out to more than 400 team members across Genomics and the Trait Development Pipeline (TDP) in a 6 month time period. This process involved complete revision of all Biotech QMS documentation, creation of procedures for six TDP functional areas across multiple sites and training for all team members. • Developed long term implementation strategy for ISO 9001:2000 and BIO ETS implementation for Biotechnology and the required organizational structure to support these activities, increasing matrix reports from 2 to 16 Quality Coordinators. • Certified ISO 9001:2000 Lead Auditor and completed Six Sigma Black Belt and LEAN Practitioner training. Monsanto, Luling, LA 2006 Luling Plant Quality Manager • Led the plant quality initiatives as listed under my previous assignment and served as the site ISO Management Representative, leading Management Reviews and overseeing the ISO compliance activities. • Responsible for review and approval of analytical methods, development and implementation of quality procedures as well as review of all plant experiments. • Also responsible for biotech community outreach and education activities. Monsanto, Luling, LA 2006-2000 QA/QC Laboratory Supervisor and Plant Quality Lead • Leader for plant quality efforts as well as laboratory operations. • Responsible for coaching and development of 41 laboratory technicians, one clerk and six professionals (three chemists, first line supervisor, lab trainer and LIMS/SAP QM manager). Developed and managed annual budget of approximately $7.5M and oversaw laboratory capital expenditures ($125k -2M annually). • Directed quality efforts, such as supplier, terminal and plant audits, development of plant quality procedures, quality investigations, specification approvals, plant experiments and product release criteria. • Reviewed and approved analytical SOPs, ensured operations met regulatory and ISO compliance and championed continuous improvement through development of new methodologies. Successfully reorganized laboratory operations, reducing manpower by 33% without impact to production, in order to better meet the business needs. • Team achieved 14 yrs incident free and developed new safety recognition program, which has been shared across Monsanto.

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