Product Deviation Resolution Expert

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Job Description

About the Role:

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.

How you will Contribute:

• 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

What you bring to Takeda:

• Typically requires a bachelor's degree in science, engineering or other related technical fields and 5+ years of related experience. Some leadership experience preferred.
• 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.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours,.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-Onsite

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - IL - Round Lake - Drug Delivery

U.S. Base Salary Range:

$99,500.00 - $156,420.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes