Senior Specialist, QA Operations; Batch Records, Deviations, Control

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

From day one, expect to make an immediate impact-on our science, on our teams, and most importantly, on patients. Learn more about Rayze Bio:

Summary

The Senior Specialist, QA Operations will help support operations through quality oversight in a Radiopharmaceutical facility in Indianapolis, IN. The Senior QA Operations specialist will be providing oversight over shop floor activities in accordance with regulatory standards and Rayze Bio procedures. The Senior QA Operations specialist will also be responsible for material and batch disposition activities. This position will utilize quality assurance knowledge in ensuring compliance in operations to support clinical development and GMP commercial operations in accordance with 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, Batch Records, and Material and Lot Disposition. This person may also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Build and maintain cross functional relationships to improve processes and resolve issues.

• Provide quality oversight on manufacturing and validation activities.

• Perform real time review of manufacturing records.

• Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures.

• Provide guidance on the handling of quality and shop floor activities.

• Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.

• 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.

• Uses AI tools to enhance individual productivity and quality of work

· 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.

Education and Experience

• 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 working in a GMP aseptic manufacturing environment preferred.

• Experience working with FDA or other regulatory authorities is preferred.

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Skills and Qualifications

· Expertise in GMP, Quality, material and product disposition

· Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles

· Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management

· Team player who can work independently to achieve objectives in a fast-paced environment

· Excellent verbal and written communication skills.

· Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.

· Knowledge of US, EU and rest-of-world cGMP…