Qa Batch Disposition Specialist Iii

Legend Biotech

Raritan, NJ, United States
**
Review manufacturing documentation
Good documentation practices (gdp)
Cgmp requirements
** Legend Biotech is hiring a QA Batch Disposition Specialist III in Raritan, NJ, to ensure quality compliance in the manufacturing of CAR-T drug products. The role involves reviewing documentation, collaborating with cross-functional teams, and contributing to process improvements. **

Job Summary

  • This exempt-level position is responsible for performing a wide range of activities to support the Manufacturing and release of CAR-T drug product for human use.
  • Review documentation for all manufacturing activities executed in accordance with Good Documentation Practices (GDP).
  • Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements.

Matching Summary

Match Score: 75

** Legend Biotech is hiring a QA Batch Disposition Specialist III in Raritan, NJ, to ensure quality compliance in the manufacturing of CAR-T drug products. The role involves reviewing documentation, collaborating with cross-functional teams, and contributing to process improvements. **

Skills & Requirements

Must-have

  • Review manufacturing documentation
  • Good Documentation Practices (GDP)
  • cGMP requirements
  • Electronic quality systems
  • SAP utilization

Nice-to-have

  • Cross-functional collaboration
  • Process improvement contribution
  • Continuous improvement focus

Key Requirements

  • Bachelor’s degree required in Life Sciences or Engineering
  • Minimum 3 years of experience in a QA role
  • Experience with batch review/release processes

Work Rights

Not specified

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