Specific responsibilities include but are not limited to: • Own change controls for manufacturing process changes • Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections. • Support Risk Assessments exercises and Microbial assessment evaluations. • Led commercial campaign readiness and effectively communicate and collaborate with cross function areas. • Assist in the generation of training materials and assist in providing traini...