R-235089 Quality Assurance Specialist - Manufacturing Support

Amgen

Base: $104,287.35 - $141,094.65 usd; bonus/equity:...
10 years of quality or manufacturing experience
Bachelor's degree in life science or engineering
Knowledge of cgmp and gdp regulations
This role serves as a vital partner to Manufacturing staff to facilitate real-time decision-making regarding quality requirements and deviations during bulk drug substance operations

Job Summary

  • This role serves as a vital partner to Manufacturing staff to facilitate real-time decision-making regarding quality requirements and deviations during bulk drug substance operations.
  • The position requires ensuring that all facilities, equipment, and processes comply with current Good Manufacturing Practices (cGMP) and other applicable regulations.
  • Amgen offers competitive Total Rewards Plans and a collaborative culture dedicated to serving patients living with serious illnesses.

Matching Summary

This role serves as a vital partner to Manufacturing staff to facilitate real-time decision-making regarding quality requirements and deviations 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 of Quality or Manufacturing experience
  • Bachelor's degree in Life Science or Engineering
  • Knowledge of cGMP and GDP regulations

Nice-to-have

  • Experience with MES and Delta-V automation systems
  • Strong collaborative partnership building skills
  • Root Cause Analysis and Deviation investigation expertise

Key Requirements

  • High school diploma/GED plus 10 years experience OR Bachelor's degree plus 4 years experience
  • Educational background in Life Science or Engineering preferred
  • Familiarity with cell banking, cell culture, and protein purification operations

Work Rights

Not specified

Tailored Resume

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