Kate Sigite Theil Email & Phone Number

St. Louis, MO, US

Edwardsville

Overall responsibility for program P&L to ensure strong financial performance.Ensures customer satisfaction and SLA’s are met.Ongoing continuous improvement in both value to the customer and financial/operational performance.Maintains communication with client executive sponsors.Incremental business development to extend the program and/or identifies new.

Greater St. Louis Area

Plan and deliver all stages of the project within a matrix organization, including, but not limited to; the introduction of new products into the facilities, process development, analytical method development and qualification, equipment purchase and qualification, and for overseeing the preparation for, execution of and close out of production batches..

Plan and deliver all stages of the project within a matrix organization, including, but not limited to; the introduction of new products into the facilities, process development, analytical method development and qualification, equipment purchase and qualification, and for overseeing the preparation for, execution of and close out of production batches..

United States

Provides leadership and experience with review and approval of incident investigations, CAPAs, Change Control documentation, technical memos, regulatory documents and commitments, and adherence to Quality Agreements. Performs the timely disposition of commercial and clinical material to allow shipment to customers, verifies cGMP compliance in raw material.

Created/Reviewed/Lead activities related to release/rejection of monoclonal antibody products and raw materials. Reviewed/Approved manufacturing batch records and analytical release testing data according to SOPs, to ensure cGMP compliance, accuracy and completeness. Created and revised SOPs, batch records, regulatory documentation and site documentation..

Initiated, coordinated, and completed quality and timely investigations relating to Engineering, Facilities Maintenance and Metrology equipment and facility failures utilizing root cause analysis tools (i.e. fishbone diagrams), as needed. Assisted Quality Assurance Compliance with internal audit inspections, responses; and FDA, Canadian and EMEA health.

Responsible for explaining and demonstrating Standard Operating Procedures utilizing training plans and assessing competency. Assisting in the creation of training courses and job aids to facilitate learning and performance and to improve compliance. Experienced in facilitating classroom and hands-on training for the production department. Maintaining the.

Associates, Applied Science

Bachelors, Organizational Management