Seeking a seasoned Investigations Lead to spearhead complex investigations across fill/finish and inspection operations. As part of our dynamic team, you will be responsible for driving process improvements, applying quality and compliance knowledge, and leading cross-functional teams through ambiguity.
Key Responsibilities:
* Lead comprehensive investigations, establishing root cause analysis, CAPAs, product impact assessments, and compliant documentation.
* Drive technical writing excellence, presenting complex topics to various audiences.
* Promote process enhancements, facilitating effective communication among stakeholders.
* Present findings to regulatory inspectors and internal auditors.
* Cultivate relationships with cross-functional teams, ensuring seamless collaboration.
Requirements:
* Bachelor's or Associate's Degree in Science or Engineering.
* 5+ years of experience in biotech/pharma manufacturing or support roles.
* Detailed technical understanding of fill/finish operations.
* Experience with project management, quality systems, and leadership.
Desirable Skills:
* Technical writing and presentation skills.
* Regulatory compliance and problem-solving expertise.