Key Responsibilities
* Review electronic and paper batch records for multiple projects in a timely manner
* Investigate red flags and comments in batch records (e.g., failed process parameters, material consumption issues, operator notes) using relevant process/data systems and cross-department collaboration
* Assess and clarify the accuracy of comments and actions on batch records, adding supplementary notes as needed in accordance with GMP, Good Documentation Practices, and ALCOA+ principles
* Collaborate with BRR team and cross-functional teams to resolve batch record issues and evaluate quality impact statements per GMP and ALCOA+ standards
* Utilize MES Syncade, DeltaV, Trackwise, SAP, LIMS, DMS, and related systems to investigate batch record issues
* Perform additional BRR tasks such as Post-Production Lifecycle Document authoring and data cleaning for reports