Step into an impactful role with OmniaBio as a Compliance Associate in Hamilton, Ontario, focusing on GMP compliance, environmental monitoring, and leadership in biomanufacturing.
This role is pivotal for ensuring adherence to GMP standards within the OmniaBio facility. You will be responsible for managing training programs, leading compliance investigations, and coordinating quality activities. Knowledge of environmental monitoring systems and regulatory frameworks in cell and gene therapy is vital to your success.
Key Responsibilities:
• Oversee documentation practices and GMP compliance
• Create departmental KPI adherence reports via SAP
• Perform timely investigations and complete deviation reports
• Identify and manage training gaps in programs
• Prepare for internal and regulatory audits as an expert
Requirements:
• Minimum 6 years of GMP experience in a CDMO
• At least 5 years in compliance or documentation roles
• Technical degree or equivalent ...