Quality Assurance Specialist - Manufacturing Support

Amgen Inc

Base: $104,287.35 - $141,094.65 usd; bonus/equity:...
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Cgmp and gdp regulatory compliance
Batch production record review and approval
Deviation and capa investigation management
** Amgen Inc. is seeking a Quality Assurance Specialist for its manufacturing support team, responsible for ensuring compliance with cGMP standards during drug substance operations. The role involves collaboration with manufacturing staff, quality oversight, and continuous improvement initiatives within the plant. **

Job Summary

  • This role provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements.
  • The position requires ensuring that facilities, equipment, materials, and processes comply with current Good Manufacturing Practices (cGMP) and other applicable regulations.
  • Amgen offers competitive Total Rewards Plans aligned with local industry standards and supports professional growth within a collaborative, science-based culture.

Matching Summary

Match Score: 75

** Amgen Inc. is seeking a Quality Assurance Specialist for its manufacturing support team, responsible for ensuring compliance with cGMP standards during drug substance operations. The role involves collaboration with manufacturing staff, quality oversight, and continuous improvement initiatives within the plant. **

Salary

Base: $104,287.35 - $141,094.65 USD; Bonus/Equity: Not specified; Benefits: Competitive Total Rewards Plans

Skills & Requirements

Must-have

  • cGMP and GDP regulatory compliance
  • Batch Production Record review and approval
  • Deviation and CAPA investigation management
  • Real-time quality decision making on floor
  • SOP and validation document authoring

Nice-to-have

  • Experience with MES and Delta-V automation systems
  • Strong collaborative partnership building skills
  • Root cause analysis and problem solving expertise
  • Health authority inspection representation experience
  • Continuous improvement implementation capabilities

Key Requirements

  • High school diploma plus 10 years experience OR Bachelor's degree plus 4 years experience
  • Educational background in Life Science or Engineering preferred
  • Experience with Quality Management Systems including Change Control and Risk Management
  • Demonstrated ability in managing Root Cause Analysis and Deviation investigations

Work Rights

Not specified

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