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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