Provide Quality assistance and oversight during manufacturing of in-process, upstream and downstream, as required. Perform Product Disposition, encompassing the review of production batch records and associated documentation required to release a production lot, as required. This individual manages the batch documentation package and maintains records. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.