Catherine Schuetz

Background

About Catherine Schuetz

Sixteen years of professional experience in various Manufacturing and Quality functions in a GMP environment, including; sterile vaccine manufacturing, product release, deviation management, environmental monitoring and Quality Operations. Proven leadership for team of Quality Operations Specialists, including hiring, managing workload to meet customer needs and product launches, providing mentoring and feedback to improve or sustain performance and performing yearly reviews. Represent Quality as the primary point of contact to Operations in Tier meetings, providing quality oversight of complex projects such as installation of new manufacturing equipment, bringing a new facility and vaccine online and for support during regulatory inspections. Experienced in authoring environmental investigations, approving environmental and manufacturing investigations including assignment of CAPA’s, approving Validation documents, Change Control documents, SOPs, Study Protocols and Reports and supporting Capitol Projects.