Quality Assurance Specialist

Amgen Australia Pty Ltd

Base: 113,191.00 usd - 131,832.00 usd; bonus/equit...
Cgmp compliance
Good documentation practices
Quality management systems
This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations

Job Summary

  • This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
  • Amgen’s Quality Assurance Specialist provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems.
  • Our award-winning culture is collaborative, innovative, and science based.

Matching Summary

This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.

Salary

Base: 113,191.00 USD - 131,832.00 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • cGMP compliance
  • Good Documentation Practices
  • Quality Management Systems
  • Deviation investigations
  • Root Cause Analysis

Nice-to-have

  • Collaborative partnerships
  • Continuous improvement
  • Science based culture
  • Patient focused mission

Key Requirements

  • High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Doctorate degree and 0 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • Life Science or Engineering educational background
  • Familiarity with cell banking, cell culture, and protein purification operations
  • Experience with Exceptions, Change Control, Risk Management and Disposition
  • Familiarity with Computer / Automation systems
  • Experience managing Root Cause Analysis / Deviation investigations
  • Experience with health authority inspections

Work Rights

Not specified

Tailored Resume

Cover Letter