Manufacturing Investigation, Principal Analyst

Takeda • Round Lake, IL

12d • Onsite

About The Position

The Manufacturing Investigation, Principal Analyst, addresses and expedites product deviations within our quality management system. You will ensure compliance with regulatory agencies and improve deviation management to prevent recurring events. By maintaining unified product defect investigation procedures, the Principal Analyst contributes to the continuous improvement of manufacturing processes. Additionally, the Manufacturing Investigation Principal Analyst will lead L1 Change Controls to implement process changes and improvements. You will provide technical support to the manufacturing functions which includes filling, inspection, and packaging operations. By maintaining high-quality standards, you will support Takeda's mission to deliver better health to people and a brighter future to the world.

Requirements

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

Nice To Haves

• Some leadership experience preferred.

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 Investigation 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 the 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

Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees