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.
Provides oversight to operations on the shop 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 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 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.
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
Implements and ensures adherence of appropriate 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.
BS/BA in Biological Sciences or equivalent relevant career experience.
3 + years of experience in a Pharmaceuticals environment.
Practice knowledge and understanding of cGMPs.
Excellent written and verbal communication skills required, including Responsible Business Communication.
Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
Must be proficient with MS Office applications.