Associate Specialist, Quality Assurance

medhunter.de

Base: $71,900.00 - $113,200.00; bonus/equity: annu...
Hybrid
Cgmp compliance knowledge
Usda regulations experience
Batch record review and approval
This role serves as the Quality Integrated Process Team Representative for Fermentation, Downstream, and Single Use Bioreactors manufacturing areas

Job Summary

  • This role serves as the Quality Integrated Process Team Representative for Fermentation, Downstream, and Single Use Bioreactors manufacturing areas.
  • The successful candidate will navigate various perspectives of Planning, QA, and Production while holding Safety and Quality as primary values.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k).

Matching Summary

This role serves as the Quality Integrated Process Team Representative for Fermentation, Downstream, and Single Use Bioreactors manufacturing areas.

Salary

Base: $71,900.00 - $113,200.00; Bonus/Equity: Annual bonus and long-term incentive available; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • cGMP compliance knowledge
  • USDA regulations experience
  • batch record review and approval
  • deviation management and CAPA
  • change control documentation
  • inspection readiness preparation

Nice-to-have

  • vaccine manufacturing familiarity
  • strong microbiology background
  • project management experience
  • SAP Aera Reliance systems
  • continuous improvement mindset

Key Requirements

  • Bachelor's degree required (Science preferred)
  • Minimum 2 years Quality experience in regulated industry
  • 5 years relevant industry experience with Associate's degree
  • Experience with investigations and risk assessment

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter