Transform your career with OmniaBio in Hamilton, ON, as an Associate I for Commissioning Qualification and Validation. This role emphasizes supporting GMP compliance and documentation development.
In this position, you will focus on validating key operational deliverables including equipment and systems while ensuring all processes meet regulatory standards. Your background in CQV and strong technical writing skills will be utilized to develop documentation and SOPs, playing a pivotal role in aiding the success of cutting-edge cell and gene therapies.
Key Responsibilities:
• Validate equipment, facilities, and computerized systems
• Collaborate with various internal teams on documentation needs
• Prepare temperature mapping and alarm documentation
• Manage deviations and change controls documentation
• Review CQV documentation regularly for compliance
Requirements:
• Minimum 1 year experience in CQV in GMP settings
• Relevant post-secondary education prefe...