Stability Program Coordinator

Stability Program Coordinator is responsible for drafting, reviewing, and maintaining stability protocols and amendments, defining study design parameters, and overseeing sample chain-of-custody, storage placement, and reconciliation. The role requires excellent written and oral communication skills, an understanding of cGMP requirements, and the ability to work on own initiative and as part of a team.

Requirements

• Degree Qualification (Science/Technical/Quality or related)
• 4 years’ experience in the biotechnology and/or pharmaceutical industry
• Excellent written and oral communication skills
• An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance
• Ability to work on own initiative and as part of a team
• Excellent time management & organizational skills
• An understanding of GMP, ICH, USP and global compendia regulations and guidance
• Demonstrated understanding of continuous quality/process improvement tools
• Proven ability to work cross-functionally, focusing on meeting and tracking to schedules
• Flexible, self-motivated, and embracing an interdependent work culture
• Organization skills – Ability to manage multiple priorities and know when to escalate issues for resolution