Stability Program Coordinator

Laboratory Animal Management Association

Stability protocols and amendments
Ich guidelines
Glims verification
We use the power of leading-edge science to save and improve lives around the world

Job Summary

  • We use the power of leading-edge science to save and improve lives around the world.
  • Draft, review, and maintain stability protocols and amendments in alignment with ICH guidelines, internal SOPs, and regulatory commitments.
  • Partner with QC Leads on methods, method changes, and specification updates.

Matching Summary

We use the power of leading-edge science to save and improve lives around the world.

Skills & Requirements

Must-have

  • Stability protocols and amendments
  • ICH guidelines
  • GLIMS verification
  • GMP, GDP, data integrity
  • Investigate OOS/OOT/atypical trends
  • Audit/inspection readiness

Nice-to-have

  • Continuous quality/process improvement
  • Embracing an interdependent work culture
  • Digitalization efforts and KPI reporting

Key Requirements

  • 4 years’ experience in biotech/pharma
  • Degree in Science/Technical/Quality
  • Understanding of cGMP requirements
  • Understanding of GMP, ICH, USP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter