Quality Assurance Specialist - Manufacturing Support

Amgen UK

Base: $104,287.35 - $141,094.65 usd; bonus/equity:...
Not specified
Cgmp and gdp compliance knowledge
Batch production record review
Deviation investigation experience
Amgen UK is seeking a Quality Assurance Specialist for its manufacturing support team, focusing on ensuring compliance with quality standards in drug substance operations. The role requires extensive experience in quality assurance and manufacturing processes, with the goal of enhancing product quality and safety while collaborating closely with manufacturing staff

Job Summary

  • This role serves as a vital partner to Manufacturing staff, facilitating real-time decision-making regarding quality requirements and deviations during bulk drug substance operations.
  • The specialist provides comprehensive oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
  • Amgen offers a collaborative culture where employees can make a lasting impact on patients' lives while transforming their careers through competitive benefits and professional growth opportunities.

Matching Summary

Match Score: 85

Amgen UK is seeking a Quality Assurance Specialist for its manufacturing support team, focusing on ensuring compliance with quality standards in drug substance operations. The role requires extensive experience in quality assurance and manufacturing processes, with the goal of enhancing product quality and safety while collaborating closely with manufacturing staff.

Salary

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

Skills & Requirements

Must-have

  • cGMP and GDP compliance knowledge
  • Batch Production Record review
  • Deviation investigation experience
  • Change Control and CAPA management
  • SOP authoring and approval

Nice-to-have

  • Experience with MES and Delta-V systems
  • Root Cause Analysis expertise
  • Collaborative partnership building
  • Continuous improvement mindset
  • Regulatory agency inspection experience

Key Requirements

  • High school diploma plus 10 years experience OR Bachelor's degree plus 4 years experience
  • Background in Life Science or Engineering preferred
  • Experience with Quality Management Systems including Risk Management
  • Ability to manage Root Cause Analysis and Deviation investigations

Work Rights

Not specified

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