Manufacturing Investigation, Principal Analyst

Role Summary

The Manufacturing Investigation, Principal Analyst addresses and expedites product deviations within the quality management system, ensuring regulatory compliance and improving deviation management to prevent recurrence. The role contributes to continuous improvement of manufacturing processes and leads L1 Change Controls to implement process changes and improvements, providing technical support to manufacturing functions including filling, inspection, and packaging operations.

Responsibilities

• Investigate and respond to product deviations, ensuring compliance with quality management procedures
• Monitor trends in deviations to recommend corrective and preventive actions
• Maintain unified product defect investigation operating procedures
• Provide technical expertise to improve deviation management and prevent reoccurring events
• Collaborate with all partners to ensure resolution of issues
• Conduct and document investigations promptly to support the closure of non-conformances to meet product fulfillment dates
• Lead L1 Change Controls to implement process changes and improvements
• Support problem solving sessions through application of problem-solving tools and methods to lead investigation teams; lead routine and complex investigations
• Audit and monitor processes to ensure compliance with internal and regulatory standards
• Conduct product integrity testing, including coloring, fitting, pattern, and wet processing
• Mentor junior Lead Investigators and contribute to the department strategy

Qualifications

• Typically requires a bachelor's degree in science, engineering or related technical field and 5+ years of related experience; some leadership experience preferred
• Apply advanced investigation techniques independently, analyze complex situations and implement solutions
• Independently identify flaws in Corrective And Preventive Action processes and implement corrective measures
• Conduct root cause analysis in moderately complex situations
• Understand and apply Good Manufacturing Practices independently in different contexts
• Accomplish Quality Assurance tasks independently in routine and complex situations
• Conduct audits with comprehensive understanding in complex scenarios
• Demonstrate advanced writing skills to produce clear documentation
• Ensure safety assurance independently, applying safety concepts in different contexts
• Apply quality control principles independently and implement important concepts
• Demonstrate practical experience in biotechnology, performing tasks independently and understanding biological processes
• Independently apply process improvement techniques
• Communicate verbally with clarity and confidence

Education

• Bachelor's degree in science, engineering or related technical field