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Job Description

Senior Quality Analyst- Nights

Takeda Pharmaceuticals

About the Role:

You will perform all primary Quality Assurance activities for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. The incumbent shall provide daily Quality on the Shop Floor oversight to manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and resolution of issues, participating in troubleshooting and problem solving of manufacturing issues and supporting daily Return to Operation assessment and Change Control (insignificant changes) process.

You will provide Quality Assurance support to Site Critical Systems, Facilities and Engineering processes. The incumbent shall ensure compliance with cGMP, GDDP, and company procedures and support internal and external audits. Identify potential Quality and compliance risk in activities and processes according to procedural requirements, Takeda Quality Standards and practices. Provide assessments to support good understanding and knowledge of current regulatory requirements i.e., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements. Uphold Takeda's Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and owning and demonstrating commitment to Quality.

How you will Contribute:

• Partner up with Manufacturing for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.
• Perform scheduled and unscheduled walkthroughs of Manufacturing, facilities, and supporting areas for verification of acceptable cGMP Facilities and equipment conditions.
• Obtain resolution on issues identified as non-conformance. Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements. Help document issues with immediate corrections and corrective actions.
• Work with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, produce cost savings, and provide new product support.
• Perform Batch Record Review to ensure compliance with procedures.
• Perform initial investigations and reviews Deviations, CAPAs, and User Interventions, etc.
• Identify areas for improvements to reduce recurring non-conformances and improve.
• Review and release batch records and associated documents against Standard Operating (SOP) for accuracy and assure compliance to procedures based on regulatory requirements and internal guidelines.
• Place plasma lots/material under containment or release plasma lots/material in JDE.
• Approve plasma units for further processing
• Work with change owners to ensure change packages are accurate and meet requirements set forth.
• Develop and execute project(s) as assigned by management.
• Administer and maintain relevant databases, prepare and issue reports as defined by the area.
• Help with internal self-inspections and external audits by collecting and reviewing documents assigned by management
• Provide guidance and training of employees within the department as assigned by management.
• Provide guidance to members of other departments with regards to critical step verification.
• Support activities for other departments as assigned by management.

What you bring to Takeda:

• Bachelor's Degree in Science-Chemistry or Biological Science is preferred. 4+ years of experience.
• Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).
• General knowledge of biopharmaceutical / biotech manufacturing industry and systems.
• Good investigational experience. See the actual process on the floor (GEMBA) where issue occurred and recommend immediate corrections and corrective actions for determined cause.
• Be able to perform and analyze trending using DeltaV system and/or EBM.
• Be able to create spreadsheets and prepare reports and Power Point presentations on the computer.
• Be able to support department / plant goals.
• Yellow Belt/ Green Belt training or certification preferred.

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.
• Be able to approve investigations as assigned
• Be creative with ideas to improve through process simplification, automation, and digitalization.
• Have good critical thinking and problem-solving skills (DMAIC and Lean).
• Need to remove all make-up, jewelry, contact lenses, nail polish 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.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be able to lift, push, pull and carry up to 25 lbs.
• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.

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-MA1

Takeda Compensation and Benefits Summary

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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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