Quality Assurance Specialist, Cellular Therapeutics

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States
Base: $79,560.00 - $115,720.80/annual; bonus/equit...
Hybrid
Fact accreditation inspection coordination
Fda gmp/gtp regulatory knowledge
Hematopoietic cell transplant experience
The role ensures compliance with federal, state, and local regulations including FACT, JC, FDA, CLIA, OSHA, and DPH standards for the Cellular Therapeutics Laboratory

Job Summary

  • The role ensures compliance with federal, state, and local regulations including FACT, JC, FDA, CLIA, OSHA, and DPH standards for the Cellular Therapeutics Laboratory.
  • Responsibilities include performing FACT self-assessments, reviewing standard operating procedures, and conducting internal audits to maintain program integrity.
  • The position offers a competitive annual salary range of $79,560.00 to $115,720.80 along with comprehensive benefits and career advancement opportunities.

Matching Summary

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

Salary

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

Skills & Requirements

Must-have

  • FACT accreditation inspection coordination
  • FDA GMP/GTP regulatory knowledge
  • Hematopoietic Cell Transplant experience
  • Non-conforming form review
  • RCA/CAPA investigation execution

Nice-to-have

  • Process improvement project leadership
  • Professional committee membership participation
  • Effective peer-directed communication skills
  • Collaborative team environment engagement

Key Requirements

  • Bachelor's degree required
  • 3 years healthcare setting experience
  • NAHQ or ASQ certification preferred
  • Knowledge of FACT and AABB standards
  • 3 years Hematopoietic Cell Transplant experience preferred

Work Rights

Not specified

Tailored Resume

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