External Quality Assurance Associate Ii

Rentschler

Milford, MA, United States
Base: $80,000 - $105,000; bonus/equity: annual dis...
Knowledge of fda cgmp requirements
Experience with electronic quality systems
Quality document review and approval
Rentschler Biopharma is a leading CDMO focused on bioprocess development and production of complex biopharmaceuticals with a global footprint

Job Summary

  • Rentschler Biopharma is a leading CDMO focused on bioprocess development and production of complex biopharmaceuticals with a global footprint.
  • The External Quality Assurance Associate II will serve as the Quality Point of Contact between QA and customers, ensuring compliance with regulatory and quality standards.
  • The company offers a competitive total rewards package including base salary, discretionary bonus, medical insurance, and a generous 401K program.

Matching Summary

Rentschler Biopharma is a leading CDMO focused on bioprocess development and production of complex biopharmaceuticals with a global footprint.

Salary

Base: $80,000 - $105,000; Bonus/Equity: Annual discretionary bonus program; Benefits: Medical insurance, 401K program, other wellness benefits

Skills & Requirements

Must-have

  • Knowledge of FDA cGMP requirements
  • Experience with electronic quality systems
  • Quality document review and approval
  • Compliance to GMP in biologics manufacturing
  • Strong organizational and communication skills
  • Multi-tasking in fast paced environment

Nice-to-have

  • Professional quality certifications
  • Advanced Excel skills
  • Change control experience
  • Team player with problem solving skills
  • Experience in external quality role
  • Continuous improvement participation

Key Requirements

  • Bachelor’s Degree in STEM
  • 3+ years quality experience in biotech or pharma
  • Knowledge of biologics manufacturing processes
  • Experience with FDA cGMP regulatory requirements
  • Professional quality certifications preferred

Work Rights

Not specified

Tailored Resume

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