Danielle Piña Email & Phone Number

Findlay, Oh, Us

Assess events that occur and the potential impact it may have on the product's SISPQ parameters, and make a determination whether it qualifies as an Atypical event or if it necessitates escalation to a Notification. Create a Notification with details that were given by both Operations and Quality Tech that has enough to follow when the event started, how it was discovered, what was the potential cause, and what product was impacted. Continually following up on SOP's, SWI's, WO's, PDC's, LMS, EBR, Quality event tracker, Red zone, SAP and any other request that need to be updated as we continue to change and upgrade into the electronic era. On the People Pillar Communication boardProjectsMid-year reviews & Yearly reviews for all team membersPayroll (Krono's)SharePoint site reviewTeam building meetings

United States

Thoroughly review each batch record and document for accuracy and compliance with established procedures. Once all discrepancies or errors found have been corrected then batch can be moved to be released. Batch record or Raw material maybe released after 1st level review has been completed by another review tech and all issues have been corrected. The 2nd review will then follow the release procedure and if any issue should be found the batch or document will be sent out again for corrections. If nothing is found then the material will be released fully if all labs are completed and passed. Some batches are reviewd as 2nd level released at risk without all labs being present per a WI. Releasing batches with DeviationsReleasing SBRF batchesReleasing R&D batchesRejected BatchesRework batches, sometimes having to release a rework for a rework. Validation batchesE-02