R-235089 Quality Assurance Specialist - Manufacturing Support

Amgen UK

Unknown, Unknown, United Kingdom
Base: $104,287.35 - $141,094.65 usd; bonus/equity:...
Cgmp and gdp compliance knowledge
Batch production record review and approval
Deviation investigation and root cause analysis
This role serves as a Quality Assurance Specialist responsible for Plant Quality Assurance within Amgen's advanced FleX batch facility

Job Summary

  • This role serves as a Quality Assurance Specialist responsible for Plant Quality Assurance within Amgen's advanced FleX batch facility.
  • The position requires providing real-time decision-making support to Manufacturing staff regarding quality requirements and deviations during bulk drug substance operations.
  • Amgen offers competitive Total Rewards Plans aligned with local industry standards to support professional and personal growth.

Matching Summary

This role serves as a Quality Assurance Specialist responsible for Plant Quality Assurance within Amgen's advanced FleX batch facility.

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 compliance knowledge
  • Batch Production Record review and approval
  • Deviation investigation and Root Cause Analysis
  • Change Control and CAPA management
  • SOP authoring and quality document approval

Nice-to-have

  • Experience with MES and Delta-V systems
  • Strong collaborative partnership building skills
  • Familiarity with cell banking and protein purification
  • Project management support capabilities
  • Continuous improvement implementation experience

Key Requirements

  • High school diploma plus 10 years of relevant experience OR Bachelor's degree plus 4 years
  • Educational background in Life Science or Engineering preferred
  • Demonstrated ability in managing health authority inspections and audits

Work Rights

Not specified

Tailored Resume

Cover Letter