Sr. Specialist - QA Document 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:

The Senior Document Control Specialist independently executes and oversees GxP document control and records management activities supporting Rayze Bio’s Indianapolis operations. This role functions as a senior individual contributor and subject matter expert (SME) within the Document Control program, applying established quality system frameworks to resolve non‑routine documentation and records issues. The Senior Document Control Specialist provides guidance to document authors and functional stakeholders, supports regulatory inspections, and supports regulatory inspections and contributes to site-level continuous improvement initiatives without direct people management or global program ownership.

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

• Execute full lifecycle management of controlled GxP documents.
• Review formatting, metadata, and GDP compliance.
• Issue, reconcile, and archive controlled documents.
• Manage eDMS workflows and provide troubleshooting.
• Support audits through organized document retrieval.
• Support change-related documentation (deviations, CAPAs, change controls).
• Train employees in document control procedures.
• Mentor junior specialists.
• Generate metrics and support process improvements.
• Coordinate with internal and external stakeholders to troubleshoot issues when required.
• 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 apply 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 4+ years of direct document control or quality systems experience in a regulated GxP environment (pharmaceutical, biotech, or radiopharmaceutical preferred).
• Experience working with FDA or other regulatory authorities is preferred.

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 and proven experience in FDA, EMA, or other regulatory authority.
• Well-practiced in exercising sound judgment in decision-making.
• Demonstrated prioritization and organization skills.

This is a position that requires working in an environment with radioactive materials where protective clothing, gloves, and safety glasses are required.

The noise level in the work environment is usually moderate.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Indianapolis - Rayze Bio - IN: $82,236 - $99,650

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…