Manufacturing Investigations Lead Role
Overview:
This position is responsible for leading investigations into manufacturing deviations. The role involves managing teams, conducting root cause analysis, and developing corrective actions.
The ideal candidate will have a strong technical understanding of fill/finish operations, experience with compliance and problem-solving, and excellent communication and presentation skills.
* Manage deviation investigations, including establishing investigation teams and leading root cause analysis
* Develop compliant documentation of all findings and present investigations to regulatory inspectors and internal auditors
* Drive improvements to the investigation process and project manage the investigations end-to-end
Requirements:
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role
* Detailed technical understanding of fill/finish operations and experience with compliance, problem-solving, and quality systems
* Excellent technical writing and presentation skills, ability to communicate and collaborate with technical and management staff
Personal Attributes:
* Detail-oriented with a strong focus on quality and compliance
* Ability to work under pressure and manage multiple priorities effectively
* Proactive and self-motivated with a continuous improvement mindset