Sr. Specialist, QA Incoming Materials

Quality Assurance Incoming Material Disposition Senior Specialist

Rayze Bio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. Rayze Bio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, Rayze Bio aims to be the global leader in radiopharmaceuticals.

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more

The Quality Assurance Incoming Material Disposition Senior Specialist is responsible for coordinating the receipt of deliverables to support the disposition of incoming materials such as consumables and raw materials at the Rayze Bio Indianapolis, IN facility. This position will perform review of the disposition deliverables to support disposition of materials and batches within the inventory management systems and assure materials comply with all Rayze Bio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).

The Senior Specialist provides Quality support and oversight for operations and disposition activities at the Indianapolis facility, including review and approval of Deviations, CAPAs, Change Controls, documents, and material disposition.

• Inspects consumables and raw materials per Standard Operating Procedures
• Build and maintain cross functional relationships to improve processes and resolve issues.
• Performs Quality Assurance review of documentation to support disposition of incoming materials.
• Works closely with supply chain and manufacturing with regards to discrepancy reporting, investigations and CAPAs associated with nonconforming material as well as the incoming material process.
• Drafts, revises, and approves procedural documents and material specifications.
• Performs review for department SOPs and Material Specification Documents.
• Supports warehouse personnel with concerns/issues with received material.
• Participates in Master Data management and supports master data for incoming materials.
• Leads the Indianapolis site Material Review Board.
• Works with a cross functional team to process Supplier Change Notifications and determine appropriate actions needed.
• Responsible for the Supplier Complaint (SCAR) process for non-conforming material.
• Coordinates with internal and external stakeholders to troubleshoot issues when required.
• Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation.
• Identify and report discrepancies from required work practices or procedures to management.
• Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
• Participate as requested in the response team for audits and inspections by health authorities.

• BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
• Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry.
• Experience with an Enterprise Resource Planning (ERP) system such as SAP is preferred.
• Experience working with incoming material release is…