Investigations Lead Role
We are seeking an experienced Investigations Lead to drive excellence in our organization.
* Lead investigations into fill/finish/inspection and packaging deviations, applying technical knowledge and analytical skills to identify root causes and develop corrective actions.
* Collaborate with cross-functional teams to drive improvements to the investigation process, ensuring compliance with regulatory requirements and industry standards.
* Present complex findings to regulatory inspectors and internal auditors, communicating clearly and concisely.
* Manage investigation projects from start to finish, coordinating tasks and resources effectively.
* Develop and maintain effective relationships across functions, building trust and credibility with stakeholders.
Key Responsibilities:
* Bachelor's Degree in Science or Engineering, or Associate's Degree in Science or Engineering with equivalent experience.
* At least 5 years of directly related experience in biotech/pharma manufacturing or manufacturing support roles, including process development, engineering, quality, and compliance.
* Detailed technical understanding of fill/finish operations and experience with problem-solving, root cause analysis, critical thinking, project management, and quality systems.
This is a unique opportunity for individuals with strong technical skills and leadership abilities to make a meaningful contribution to our organization.