Quality Assurance Associate II

5 days ago


Waltham, Massachusetts, United States ElevateBio Full time
About the Role

ElevateBio is a pioneering technology-driven company that's revolutionizing the field of cell and gene therapy. As a Quality Assurance Associate II, you'll play a critical role in ensuring the highest standards of quality and compliance in our manufacturing processes.

Key Responsibilities
  • Provide on-site quality oversight and support to ensure compliance with GMP regulations.
  • Conduct quality walk-throughs and process observations to identify areas for improvement.
  • Perform receipt and disposition of incoming patient apheresis material, ensuring accurate documentation and timely resolution of issues.
  • Verify production documents and labels to meet production schedules, ensuring accuracy and compliance.
  • Investigate and resolve product-related deviations, ensuring timely resolution and escalation of issues.
  • Perform batch record and logbook reviews, identifying compliance risks and escalating issues to management.
  • Collaborate with cross-functional teams to ensure seamless execution of quality-related tasks.
Requirements
  • Bachelor's degree in a relevant field, with a minimum of 3 years of experience in pharmaceutical, biotechnology, or biologics operations.
  • Experience in viral vectors, cellular, and gene therapy products is highly desirable.
  • Strong knowledge of GMPs and ability to apply them in a manufacturing environment.
  • Excellent teamwork and communication skills, with the ability to work collaboratively with cross-functional teams.
  • Experience with manufacturing investigations, deviations, and CAPA is highly desirable.
About ElevateBio

ElevateBio is a technology-driven company that's committed to accelerating the development of transformative genetic medicines. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

We're dedicated to creating a workplace that's inclusive, diverse, and supportive of our employees' growth and development. If you're passionate about quality and compliance, and want to be part of a dynamic team that's shaping the future of medicine, we encourage you to apply for this exciting opportunity.



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