Quality Assurance Specialist, Cellular Therapeutics

Center for Integration Science

Boston, MA, United States
Base: $79,560.00 - $115,720.80/annual; bonus/equit...
Hybrid
Fact accreditation inspection coordination
Fda gmp/gtp regulatory knowledge
Non-conforming form review
The role ensures compliance with federal, state, and local regulations including FACT, JC, FDA, and AABB standards for the Cellular Therapeutics and Transplantation Laboratory

Job Summary

  • The role ensures compliance with federal, state, and local regulations including FACT, JC, FDA, and AABB standards for the Cellular Therapeutics and Transplantation Laboratory.
  • Responsibilities include performing FACT self-assessments, reviewing standard operating procedures, and conducting root cause analyses for safety incidents.
  • Mass General Brigham offers a competitive salary range of $79,560.00 to $115,720.80 annually along with comprehensive benefits and career advancement opportunities.

Matching Summary

The role ensures compliance with federal, state, and local regulations including FACT, JC, FDA, and AABB standards for the Cellular Therapeutics and Transplantation Laboratory.

Salary

Base: $79,560.00 - $115,720.80/Annual; Bonus/Equity: Not specified; Benefits: Comprehensive benefits, career advancement, differentials, premiums, bonuses, and recognition programs

Skills & Requirements

Must-have

  • FACT accreditation inspection coordination
  • FDA GMP/GTP regulatory knowledge
  • Non-conforming form review
  • CAPA and RCA investigation
  • Internal audit execution
  • HCTCT program compliance

Nice-to-have

  • Process improvement project leadership
  • Professional committee membership
  • Subject matter expert communication
  • Collaborative team environment
  • Continuous education participation

Key Requirements

  • Bachelor's degree required
  • 3 years healthcare setting experience
  • Knowledge of FDA, CLIA, OSHA, DPH regulations
  • FACT, JC, and AABB accreditation standards expertise
  • NAHQ or ASQ certification preferred
  • 3 years Hematopoietic Cell Transplant experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter