. Responsibilities: Performs final batch disposition of semi-finished drug product batches for Indianapolis Parenteral products.... Lead, Mentor, and Coach Site personnel on quality matters associated with the Batch and the Batch Disposition process...
. The QA Lead is integral for launching new products, packages, processes, and CM's. The Principal Associate QA may... also be responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet...
. Participate on the Technical Review Board Evaluate and disposition batches of intermediate, if required. Ensure that documented...), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. Provide quality...
with CMs. Provide on-site support during inspections. Participate on the Technical Review Board Evaluate and disposition... of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation...
technique and adhere to gowning procedures in classified cleanroom environments. Accurately complete batch records, logbooks.... Segregate, label, and document rejected materials for quality review and disposition. Support deviation reporting, CAPA...
technique and adhere to gowning procedures in classified cleanroom environments. Accurately complete batch records, logbooks.... Segregate, label, and document rejected materials for quality review and disposition. Support deviation reporting, CAPA...