Sr. Specialist, QA Operations Job at Bristol Myers Squibb, Indianapolis, IN

  • Bristol Myers Squibb
  • Indianapolis, IN

Job Description

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.

Responsibilities

  • 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

Requirements

  • 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

Compensation: $82,236 - $99,650 base

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