Provide Quality assistance and oversight during manufacturing of in-process upstream and downstream, and other GMP processes as required. 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.
Note: Temporary Assignment with Potential to become Permanent
· Provides QA oversight to operations on the floor. Support manufacturing operations (upstream and downstream) at real time.
· Performs routine manufacturing batch production record review in support of product release in accordance with cGMPs, specifications and SOPs.
· Support manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise.
· Reviews documentation associated with production operations. Ensures adequate levels of documentation are acceptable and cGMP compliant to existing procedures.
· Review and audit production batch records to ensure adherence to Immunomedics policies, SOPs and cGMP requirements.
· Provide support to QA Batch Release to assist with batch record release and compliance issues.
· Initiate deviation reports and participate in activities for issue resolution and CAPAs.
· Participate in process improvement initiatives targeting for Right-First-Time (RFT) on documentation.
· Participates in activities associated with event resolution and CAPAs with a focus on organizing and attending cross-functional meetings to implement corrective actions.
· Implements and ensures adherence of appropriate cGMP regulations and Immunomedics quality standards.
· Write, review and approve Standard Operating Procedures (SOPs), as needed.
· Support operations to encourage a Quality Culture and ensure a safe working environment.
· Complete job-related training as required.
Knowledge and practical understanding of cGMPs.