Sr. Specialist, QA Operations
Bristol Myers Squibb
August 10, 2026
On-site
Indianapolis, IN
Operations
Summary
Senior Specialist, QA Operations provides quality oversight in a radiopharmaceutical facility (Indianapolis, IN), including shop floor oversight and material/batch disposition to support clinical development and GMP commercial operations per RayzeBio policies and global cGMP.
Responsibilities
- 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.
- Conduct periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance.
- Guide quality and shop floor handling activities.
- Support quality disposition by ensuring required documents are completed/compiled against approved procedures/specifications, including related deviations.
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other GMP documentation.
- Identify and report discrepancies to management.
- Use AI tools to enhance individual productivity and quality of work.
- Exercise sound judgment and notify management as appropriate.
- Participate in audit/inspection response teams with health authorities.
Qualifications
- BS/MS in a science-related field (preferred).
- 5+ years in quality assurance and/or compliance roles in the pharmaceutical industry.
- GMP aseptic manufacturing experience (preferred).
- FDA/regulatory authority experience (preferred).
Skills
- Expertise in GMP, quality, and material/product disposition.
- Ability to author/critically review investigations and generate conclusions using quality risk management.
- Detail-oriented; strong problem-solving and decision-making.
- Strong communication (verbal/written).
- Knowledge of US/EU/global cGMP regulations; proven experience with FDA/EMA or other authorities.
- Prioritization/organization skills.
Benefits (selected)
Medical, pharmacy, dental, vision; 401(k), disability, life insurance; PTO (flexible time off or vacation per eligibility).
Senior Specialist, QA Operations provides quality oversight in a radiopharmaceutical facility (Indianapolis, IN), including shop floor oversight and material/batch disposition to support clinical development and GMP commercial operations per RayzeBio policies and global cGMP.
Responsibilities
- 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.
- Conduct periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance.
- Guide quality and shop floor handling activities.
- Support quality disposition by ensuring required documents are completed/compiled against approved procedures/specifications, including related deviations.
- Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other GMP documentation.
- Identify and report discrepancies to management.
- Use AI tools to enhance individual productivity and quality of work.
- Exercise sound judgment and notify management as appropriate.
- Participate in audit/inspection response teams with health authorities.
Qualifications
- BS/MS in a science-related field (preferred).
- 5+ years in quality assurance and/or compliance roles in the pharmaceutical industry.
- GMP aseptic manufacturing experience (preferred).
- FDA/regulatory authority experience (preferred).
Skills
- Expertise in GMP, quality, and material/product disposition.
- Ability to author/critically review investigations and generate conclusions using quality risk management.
- Detail-oriented; strong problem-solving and decision-making.
- Strong communication (verbal/written).
- Knowledge of US/EU/global cGMP regulations; proven experience with FDA/EMA or other authorities.
- Prioritization/organization skills.
Benefits (selected)
Medical, pharmacy, dental, vision; 401(k), disability, life insurance; PTO (flexible time off or vacation per eligibility).