Finishing Technician

Position Summary: Responsible for all production specific activities to the Finishing work areas while working under current GMPs.

Controls and maintains area specific inventories using Oracle Inventory System and POMSnet Manufacturing Execution System (MES).

Essential Job Functions:


*     Assures that all operations are performed according to SOPs and procedures and reports any deviations from these procedures to Supervisor


*     Ability to complete successful gowning qualifications; adheres to proper aseptic gowning and filling techniques


*     Fills, caps and labels products while performing visual inspections in accordance with Device Master Records


*     Operates within MasterControl


*     Operates within POMSnet MES


*     Navigates production schedule via the production plan or Smartsheet with assistance


*     Operates within Microsoft Teams


*     Assures correct and legible identification is applied to the bulk product, filled bottles, labeled bottles, accountability boxes, paper/electronic batch records and other documents


*     Performs and documents line clearances at the beginning and completion of each operation


*     Completes all POMSnet processes, batch records, attachments and logs accurately while working under current GMPs


*     Performs physical counts of filled material accurately; reports any discrepancies immediately to management


*     Completes start up activities associated with production runs without assistance


*     Generates and confirms correctness of labels for bulk material, accountability boxes, labeled bottles and batch records


*     Generates and confirms accuracy of labels from POMSnet


*     Performs required tasks as an Outside Technician during the execution of Filling processes accurately without assistance


*     Troubleshoots filling units with assistance


*     Executes filling processes in the aseptic filling areas as a qualified assistant or operator; operates filling machines for reagents, calibrators, controls and other liquid fills with assistance


*     Completes process verifications with assistance as needed


*     Maintains all working areas in a clean and orderly state; assures that products are stored in the correct location, segregated, and clearly labeled


*     Maintains and monitors aseptic conditions of filling rooms through daily and weekly room cleanings


*     Maintains GMP compliance


*     Confirms all POMSnet processes, batch records, SOPs and specs are up-to-date and reflect the current procedure


*     Participates in the identification of needed revisions of SOPs and Batch Records in accordance with Fujirebio policies and applicable GMPs


*     Participates in the identification of departmental process improvements


*     Assures that all operations are performed according to SOPs and reports immediately any deviat...