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Senior Investigator, Quality Assurance
2 months ago
We are seeking a highly skilled Senior Investigator to join our team at FUJIFILM Diosynth Biotechnologies. As a Senior Investigator, you will play a critical role in ensuring the quality and compliance of our operations by leading and managing complex investigations related to drug substance manufacturing.
Key Responsibilities- Investigation Leadership: Lead and manage complex investigations related to drug substance manufacturing, ensuring timely closure and effective corrective and preventive actions (CAPAs).
- Root Cause Analysis: Identify root causes of deviations and develop effective CAPAs to prevent future occurrences.
- Collaboration and Communication: Collaborate cross-functionally and across sites to maintain alignment on process improvements and ensure effective communication of investigation findings and related actions.
- Training and Development: Coach and mentor junior staff on investigative techniques and best practices, ensuring a high level of expertise within the team.
- Process Improvement: Apply systematic methods to conduct investigations and drive process improvements, leveraging expertise in Human and Organizational Performance principles.
- Education: High School Diploma/GED with 12 years of experience in a GMP environment in the Life Sciences industry.
- Experience: Advanced knowledge of systematic cause analysis methods, expert facilitation skills, and expertise in performance improvement with a basis in Human and Organizational Performance principles.
- Skills: Expert technical writing skills, ability to interpret technical information and documentation, and ability to analyze and extrapolate data.
- Travel: Willing to travel internationally up to 25% during project phase.
- Education: Associate degree in Life Sciences or Engineering with 10 years of direct experience, or Bachelor's degree in Life Sciences or Engineering with 8 years of direct experience.
- Experience: Prior experience leading complicated manufacturing investigations and prior experience in quality or manufacturing operations.
