Senior Specialist, Qa Operations (batch Records, Deviations, Change Control)

RayzeBio

Indianapolis, IN, US
Base: $82,236 - $99,650; bonus/equity: incentive c...
Hybrid
Gmp compliance in aseptic manufacturing
Batch record review and approval
Deviation and capa investigation support
The Senior Specialist will provide quality oversight on shop floor activities and ensure compliance with cGMP standards in a radiopharmaceutical facility

Job Summary

  • The Senior Specialist will provide quality oversight on shop floor activities and ensure compliance with cGMP standards in a radiopharmaceutical facility.
  • Responsibilities include real-time review of manufacturing records, approving deviations and change controls, and supporting the Qualified Person for EU dose release.
  • The role offers competitive compensation ranging from $82,236 to $99,650 along with comprehensive health, financial, and work-life benefits.

Matching Summary

The Senior Specialist will provide quality oversight on shop floor activities and ensure compliance with cGMP standards in a radiopharmaceutical facility.

Salary

Base: $82,236 - $99,650; Bonus/Equity: Incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), unlimited PTO options

Skills & Requirements

Must-have

  • GMP compliance in aseptic manufacturing
  • Batch record review and approval
  • Deviation and CAPA investigation support
  • Change control documentation review
  • Material and lot disposition activities

Nice-to-have

  • Experience with FDA or EMA regulatory authorities
  • Knowledge of EU Qualified Person processes
  • Ability to use AI tools for productivity
  • Cross-functional relationship building skills
  • Fast-paced environment adaptability

Key Requirements

  • BS/MS degree in science related field
  • Minimum 5 years QA experience in pharmaceutical industry
  • Experience in GMP aseptic manufacturing environment preferred

Work Rights

Not specified

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