Senior Quality Assurance Specialist

2 days ago


Los Angeles, California, United States Takeda Pharmaceutical Full time
About the Role

We are seeking a highly skilled Quality Assurance professional to join our team at Takeda Pharmaceutical. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes, and for identifying and mitigating potential risks to our operations.

Key Responsibilities
  • Perform quality assurance activities for Teardown, Fractionation, and Purification, observing cGMP, GDDP, FDA, and regulatory standards, ISO requirements, and internal standard operating procedures.
  • Provide daily quality oversight on the shop floor, reviewing batch records and documentation for accuracy and compliance with procedures.
  • Participate in troubleshooting and problem-solving of manufacturing issues and support daily Return to Operation assessment and Change Control process.
  • Assure compliance with cGMP, GDDP, and company procedures, internal and external audits, and identify potential quality and compliance risks in activities and processes.
Requirements
  • High school diploma or GED, with 6+ years of experience or AA or higher with 4+ years related work experience.
  • Knowledge of regulations, application of Good Data and Documentation Practices (GDDP), and current Good Manufacturing Practices (cGMP).
  • General knowledge of biopharmaceutical/biotech manufacturing industry and systems.
  • Good investigational experience, critical thinking, and problem-solving skills (DMAIC and Lean).
What We Offer

Takeda offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment, and we welcome applications from qualified candidates from all backgrounds.

Please note that this is a full-time position, and the successful candidate will be required to work multiple shifts, including weekends, and may be asked to work supplemental hours. The position is based in Los Angeles, CA, and the successful candidate will be required to work in a cold, wet environment, and may be required to wear personal protective equipment (PPE) and other clean room garments daily.



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