Sr. Specialist, QA Operations
Bristol Myers Squibb · Rayzebio, IN
QualityFull-time$82k–$100kCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Senior Specialist in QA Operations to oversee quality compliance at its Indianapolis radiopharmaceutical facility. The role focuses on manufacturing oversight, batch disposition, and regulatory adherence in support of clinical and commercial operations.
What they're looking for
- BS or MS degree in science-related field (biology, biochemistry, chemistry, engineering, or related discipline)
- Minimum 5 years QA and/or compliance experience in pharmaceutical industry
- GMP aseptic manufacturing environment experience preferred
- FDA or other regulatory authority interaction experience preferred
- Expertise in GMP, quality, material and product disposition
- Knowledge of U.S., EU, and global cGMP regulations
- Strong technical writing, investigation, and risk management capabilities
What you'll be doing
- Provide quality oversight of manufacturing, validation, and shop floor activities
- Review and approve deviations, CAPAs, change controls, batch records, and disposition documentation
- Conduct real-time review of manufacturing records and periodic facility compliance walkthroughs
- Support investigations and validation documentation approvals; coordinate with Qualified Person for EU dose release
- Participate in audit and inspection response teams; identify and report procedural discrepancies
Privacy & handoff
This role links to Bristol Myers Squibb's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.