R-235089 Quality Assurance Specialist - Manufacturing Support

Amgen Australia Pty Ltd

Base: $104,287.35 - $141,094.65 usd; bonus/equity:...
10 years quality or manufacturing experience
Cgmp and gdp compliance knowledge
Batch production record review and approval
This role serves as a Quality Assurance Specialist responsible for Plant Quality Assurance to facilitate real-time decision-making regarding quality requirements during bulk drug substance operations

Job Summary

  • This role serves as a Quality Assurance Specialist responsible for Plant Quality Assurance to facilitate real-time decision-making regarding quality requirements during bulk drug substance operations.
  • The position requires providing coaching and guidance to Manufacturing, Quality Control, Supply Chain, and Facilities staff to ensure compliance with current Good Manufacturing Practices and other applicable regulations.
  • Amgen offers competitive Total Rewards Plans aligned with local industry standards and supports professional growth within an inclusive, collaborative, and science-based culture.

Matching Summary

This role serves as a Quality Assurance Specialist responsible for Plant Quality Assurance to facilitate real-time decision-making regarding quality requirements during bulk drug substance operations.

Salary

Base: $104,287.35 - $141,094.65 USD; Bonus/Equity: Not specified; Benefits: Competitive Total Rewards Plans including health and well-being support

Skills & Requirements

Must-have

  • 10 years quality or manufacturing experience
  • cGMP and GDP compliance knowledge
  • Batch Production Record review and approval
  • Deviation investigation and Root Cause Analysis
  • Change Control and CAPA management

Nice-to-have

  • Life Science or Engineering educational background
  • Experience with MES, Delta-V, PI data historian
  • Strong collaborative partnership building skills
  • Familiarity with cell banking and protein purification
  • Experience leading continuous improvement initiatives

Key Requirements

  • High school diploma plus 10 years experience OR Bachelor's degree plus 4 years experience
  • Understanding of cGMP biotech manufacturing regulations in multi-product environments
  • Demonstrated ability in problem solving and managing deviation investigations

Work Rights

Not specified

Tailored Resume

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