Quality Assurance Specialist

1 day ago


San Francisco, California, United States Axelon Full time
Quality Assurance Specialist

At Axelon, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Investigational Cellular Therapy Group, you will play a critical role in ensuring the quality and integrity of our cellular therapy development and manufacturing processes.

Key Responsibilities:
  • Perform quality assurance activities for the Investigational Cellular Therapy Group, UCSF HICTF and GMP Facility, and the Pediatric Cellular Therapy Laboratory.
  • Work closely with academic groups, regulatory affairs, manufacturing, operations, and QC groups to ensure compliance with regulatory requirements.
  • Develop and implement quality assurance procedures and protocols to ensure the quality and integrity of our cellular therapy products.
  • Conduct regular audits and inspections to ensure compliance with regulatory requirements and Axelon's quality policies.
  • Collaborate with cross-functional teams to identify and implement process improvements.
Requirements:
  • Bachelor's degree in a related area and/or equivalent experience/training.
  • At least five years' experience in a quality role in an FDA-regulated industry.
  • Strong knowledge of relevant Federal and State regulations and policies.
  • Excellent communication and problem-solving skills.
  • Ability to work in a team-oriented setting and prioritize work with minimal direction.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



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