Stability Program Coordinator

Newyorkbioconnect

Unknown
Stability protocol drafting and review
Ich guidelines compliance
Sample chain-of-custody management
We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions that advance disease prevention and treatment in people and animals

Job Summary

  • We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions that advance disease prevention and treatment in people and animals.
  • The role involves drafting and maintaining stability protocols, managing sample logistics, ensuring data integrity, and supporting regulatory submissions and audits.
  • This position requires partnering with global teams and driving improvements in stability workflows, scheduling, and data visualization to support continuous quality improvement.

Matching Summary

We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions that advance disease prevention and treatment in people and animals.

Skills & Requirements

Must-have

  • Stability protocol drafting and review
  • ICH guidelines compliance
  • Sample chain-of-custody management
  • GLIMS system proficiency
  • GMP and GDP adherence
  • Data integrity and document control
  • Trend analysis and OOS investigation

Nice-to-have

  • Lean Six Sigma experience
  • Cross-functional collaboration
  • Digitalisation and KPI reporting support
  • Flexible and self-motivated work culture
  • Statistical literacy for trend analysis

Key Requirements

  • Degree in Science/Technical/Quality or related
  • 4 years’ experience in biotechnology or pharmaceutical industry
  • Understanding of cGMP requirements
  • Knowledge of GMP, ICH, USP and global compendia regulations
  • Ability to work independently and in a team
  • Excellent communication and organizational skills

Work Rights

Not specified

Tailored Resume

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