tracey flanders

* Focused in revising Standard Operating Procedures (SOPs), master batch records, and other pertinent manufacturing documentation according to cGMPs incorporating changes and standardizing process flow. Investigates manufacturing discrepancies and implements Corrective and Preventative Actions (CAPA). Initiates and completes site and global change controls, as necessary. Actively participates in the formulation of commercially manufactured Priorix® as an aseptic gown certified operator. * Collaborates with Quality Assurance, Quality Control, etc regarding SOP revisions/approvals, * Master batch record revisions/approvals, manufacturing investigations, and other cGMP * documentation, as required. * Provides daily compliance support to Formulation, Filling, Lyophilization (FFL) value stream * consistent with the value stream’s goals, while meeting stringent timelines. * Contributed to the successful manufacture of Priorix® Consistency Lot production as a * formulation operator and deviation lead investigator. * Provides cGMP training as necessary.

* Focused on preparation of biological media and buffers according to cGMPs in clinical manufacturing pilot plant for Phase I/II clinical trial material Coordinated, scheduled, and executed Media/Buffer formulations, and performed Clean-in-Place and Steam-in-Place of equipment according to Master Batch Records, and SOPs. * Collaborated with other departments (Compliance, Quality Assurance, etc) on SOPs, master * batch records, investigations, and documentation. * Authored/revised SOPs, master batch records, and other pertinent manufacturing * documentation as necessary. * Trained 3 employees on the operation of media/buffer equipment and manufacturing processes. * Received Encore awards including one for supporting other JNJ companies during their AWFI * shutdown. * Improved process efficiency by validating 750L Single Use Mixer for use in manufacturing * biological media and buffer formulations which reduced the total number of executed media and * buffer batch records required for release of a product.

Investigates manufacturing discrepancies and implements Corrective and Preventative Actions (CAPA). Initiates and completes site and global change controls, as necessary. Revises Standard Operating Procedures (SOPs), master batch records, and other pertinent manufacturing documentation according to cGMPs incorporating changes and standardizing process flow.