Assoc. Spclst, Quality Control

med-in.at

Dunboyne, Ireland
Hybrid
Master's degree in science or quality disciplines
5 years biotechnology or pharmaceutical experience
Strong understanding of cgmp and fda regulations
This role involves developing and coaching the Quality Control team to drive a high-performance culture within a cutting-edge biologics facility

Job Summary

  • This role involves developing and coaching the Quality Control team to drive a high-performance culture within a cutting-edge biologics facility.
  • The successful candidate will perform advanced assays requiring precise analytical skills while ensuring compliance with FDA and cGMP regulations.
  • The position offers the opportunity to support regulatory submissions and inspection readiness for key medicines being commercialized globally.

Matching Summary

This role involves developing and coaching the Quality Control team to drive a high-performance culture within a cutting-edge biologics facility.

Skills & Requirements

Must-have

  • Master's degree in Science or Quality disciplines
  • 5 years biotechnology or pharmaceutical experience
  • Strong understanding of cGMP and FDA regulations
  • Expertise in ELISA, PCR, and Bio-Assays
  • Experience with analytical method validation

Nice-to-have

  • Lean Six Sigma experience
  • Leadership and coaching skills
  • Continuous improvement environment mindset
  • Strong problem-solving capabilities

Key Requirements

  • Master's degree with 5 years experience OR PhD with 3 years
  • Knowledge of ICH, USP, and global compendia regulations
  • Experience with DMAIC, Lean QA, or 5S tools

Work Rights

Not specified

Tailored Resume

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