Deviation Investigator Indianapolis - RayzeBio - IN R1604843

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:

The Deviation Investigator leads compliant manufacturing deviation investigations in a GMP radiopharmaceutical environment. The role partners with cross-functional teams to assess product quality impact, determine root cause, define CAPAs, and support timely product release and quality commitments.

• Lead, document, and close manufacturing deviation investigations in alignment with GMP requirements and internal procedures.
• Apply root cause analysis tools and risk-based decision-making to assess scope, recurrence, and product quality impact.
• Review batch records, equipment records, electronic data, logbooks, environmental monitoring, analytical data, and other supporting documentation.
• Partner with Manufacturing, Quality, Engineering, Validation, MS&T, and other SMEs to gather evidence and develop scientifically justified conclusions.
• Develop and manage CAPAs, including effectiveness criteria, due dates, and timely closure.
• Draft and revise GMP documentation, including deviations, CAPAs, SOPs, forms, change controls, reports, and supporting records.
• Monitor trends, KPIs, and recurring issues to support continuous improvement, inspection readiness, and quality system performance.
• Support internal audits, health authority inspections, product release timelines, and other site business needs as assigned.

• Bachelor’s or master’s degree in a scientific, engineering, pharmaceutical, biotechnology, or related field; equivalent experience may be considered.
• 0–2 years of experience in GMP manufacturing, quality, validation, MS&T, technical operations, or a related regulated environment.
• Experience in radiopharmaceutical, sterile injectable, aseptic, biologic, pharmaceutical, or similar regulated manufacturing preferred.
• Experience with deviation investigations, root cause analysis, CAPA development, GMP documentation, and inspection readiness preferred.

• Strong technical writing skills and ability to produce clear, audit-ready GMP documentation.
• Working knowledge of cGMP, quality systems, deviation management, CAPA, change control, and data integrity expectations.
• Strong analytical, organizational, interpersonal, facilitation, and communication skills.
• Ability to manage multiple priorities and drive investigations to closure in a fast-paced environment.
• High degree of ownership, independence, accountability, sound judgment, ethics, and confidentiality.
• Proficiency with electronic quality systems, document management systems, Microsoft Office, and data review tools preferred.

The employee is regularly required to sit, stand, walk, reach, and communicate. The role may require occasional lifting or moving up to 30 pounds and use of close and distance vision.

This position may require work in or support of a GMP cleanroom environment, including gowning, protective clothing, controlled-area procedures, and radioactive material handling. The noise level is generally moderate.

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Indianapolis - Rayze Bio - IN: $34.05 - $41.26per hour

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and…