Job Overview:
The Quality Disposition Specialist will perform activities supporting dispositioning product and/or raw materials while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Passage Standard Requirement Documents. The Quality Disposition Specialist will perform reviews and release of all records associated with external manufacturing including drug substance, fill/finish bulk product and finished drug product.
Responsibilities:
- Perform product release activities, including reviews of batch records, analytical test data and related documentation for product release/disposition
- Review batch records to support new and existing products
- Prepare and archive final batch documentation
- Assist in the coordination of activities to all activities to ensure adequate supply chain processes in place for any final product for utilization or shipment
- Review internal document for accuracy and compliance with cGMPs and Passage Bio expectations
- Participate in cross-functional teams to support department and company goals
- Perform additional QA functions as required, including audit preparation, investigations, and collection of KPIs
- Support special project team activities, as needed.
Requirements:
- Bachelor’s degree required.
- 2+ years of relevant experience for QA Associate level, experience with biologics or cell/gene therapies preferred
- Have an understanding of biologics manufacturing operations, quality control laboratory processes and associated quality systems is preferred
- Possess good written, verbal and interpersonal communication skills and the ability to effectively and comfortably interact cross functionally
- Strong attention to detail
- Able to prioritize multiple assignments and changing priorities