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Job Description

About the role

As a Senior Quality Assurance Specialist, you will be on site to provide Quality Assurance support for Manufacturing process. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. You will provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members. You will also perform GEMBA's in QC and provide necessary support. You will report to the Director of Quality Assurance.

How you will contribute

• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with laboratory supervisors or other involved departments.
• Lead ongoing, daily departmental Quality Assurance support for QC and attend QC meeting to assess the situations and workload.
• Active participant in lab investigations through each step of the process
• Review documents such as Deviations, LIR's, OOL's, OOR, Protocols authored by QC organization.
• Approve Analytical Method Validation/Transfer Protocols and Reports
• Participate in problem solving sessions and in rDMAIC's.
• Support internal and external laboratory audit readiness efforts.
• Provide training to local employees and others on relevant areas.

What you bring to Takeda

• Typically requires bachelor's degree in science, engineering, or other related technical field. 3+ years of related experience. Bachelors' Degree in Chemistry or Biological Science.
• Knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Knowledgeable of laboratory tests / equipment including the use of statistical method.
• Knowledge of basic chemical and biological safety procedures.
• Understanding of manufacturing and facility processes.

What Takeda can offer you

• May work in controlled environments requiring special gowning. Will be require to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
• In general, you will have a combination of sedentary work, standing work, and walking around observing conditions in the facility.
• May be assigned to a different shift to meet needs. Must be willing to work off shift hours.
• Will work supplemental hours to complete work commitments.

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.

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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.

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U.S. Base Salary Range:

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.

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