Manufacturing Investigation, Principal Analyst

Job Details
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Job Description
About the Role:
The Manufacturing Investigation, Principal Analyst, is responsible for addressing and expediting product deviations within the company's quality management system. This role ensures compliance with regulatory agencies and optimizes 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. The incumbent provides technical support to the manufacturing functions which includes filling, inspection, and packaging operations. By maintaining high-quality standards, this role supports 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 and analyze trends in deviations to recommend corrective and preventive actions
• Maintain and update unified product defect investigation operating procedures
• Provide technical expertise to optimize deviation management and prevent reoccurring events
• Collaborate with internal and external stakeholders to ensure effective communication and resolution of issues
• Conduct and document Investigation in a timely manner to support the on-time 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 coordinate and/or 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.
• Applies advanced investigation techniques independently, capable of analyzing complex situations and implementing solutions.
• Independently identifies flaws in Corrective And Preventive Action processes and implements corrective measures effectively.
• Conducts root cause analysis with minimal guidance, applying it in moderately complex situations.
• Fully understands and applies Good Manufacturing Practices independently in various contexts.
• Executes Quality Assurance tasks independently, applying concepts effectively in routine and complex situations.
• Conducts audits with comprehensive understanding, applying principles in complex scenarios.
• Demonstrates advanced writing skills, capable of producing clear and concise documentation.
• Ensures safety assurance independently, applying safety concepts effectively in various situations.
• Applies quality control principles independently, understanding and implementing key concepts.
• Demonstrates practical experience in biotechnology, performing tasks independently and understanding biological processes.
• Independently applies process improvement techniques, understanding and implementing fundamental concepts.
• Communicates verbally with clarity and confidence, conveying messages effectively in various 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. In this role, 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/or 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, as necessary.
• 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 best in class patient support programs. Takeda is a patient-focused company that will 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-termincentives. 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
Company
For over 240 years, Takeda's propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe-colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we're laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future
For more information, visit
Company info
Website Location 650 East Kendall Street
Cambridge
MA
02421
United States
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