The Quality Assurance Specialist focuses on the Product Disposition function, encompassing the review of production batch records and associated documentation required to release a production lot. This individual manages the batch documentation package and maintains records. This position may also be cross-trained for Raw Material Disposition, Clinical Shipments support and to provide oversight to operations on the manufacturing shop floor.
- Provides leadership to the Batch Release team.
- Reviews of production batch documentation package for batch release.
- Communicates batch release status to appropriate personnel.
- Maintains and supports material inventory, status and transfers.
- Performs and supports changeovers in production area as required.
- Prepares Certificates of Analysis (COAs).
- Assists in preparing Annual Reports as required.
- Participates in audits and other projects as appropriate.
- Supports and performs Raw Material Disposition, as needed.
- Supports and performs Clinical Shipments, as needed.
- Provides leadership and oversight to operations on the shop floor as needed.
- Lead 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.
- 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.
- Provide Training of Quality Associates where appropriate
- Complete job-related training as required.
- BS/BA in Biological Sciences or equivalent relevant career experience.
- 5 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.
Seniority Level
Associate
Industry
- Biotechnology