Quality Assurance Specialist, Cellular Therapeutics

Mass General Brigham

Boston, MA, USA
Base: $79,560.00 - $115,720.80/annual; bonus/equit...
Hybrid
Fact accreditation standards
Fda regulations
Cellular therapy product manuals
Perform FACT self-assessment as well as coordinate, compile and submit requested documentation in preparation for the FACT accreditation inspection and follow-up on any citations or findings post inspection

Job Summary

  • Perform FACT self-assessment as well as coordinate, compile and submit requested documentation in preparation for the FACT accreditation inspection and follow-up on any citations or findings post inspection.
  • Review new or revised internal standard operating procedures, job aides, worksheets, and forms to ensure compliance with FDA regulations and FACT requirements.
  • The Quality Assurance role is responsible for the Cellular Therapeutics and Transplantation Laboratory (CTTL) quality assurance goals and quality improvement activities in the context of Hematopoietic Cell Transplant and Cellular Therapy.

Matching Summary

Perform FACT self-assessment as well as coordinate, compile and submit requested documentation in preparation for the FACT accreditation inspection and follow-up on any citations or findings post inspection.

Salary

Base: $79,560.00 - $115,720.80/Annual; Bonus/Equity: Not specified; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • FACT accreditation standards
  • FDA regulations
  • Cellular Therapy product manuals
  • Internal audits
  • Quality Management Plan

Nice-to-have

  • Process improvement projects
  • Committee membership
  • Professional organizations

Key Requirements

  • Bachelor's degree required
  • 3 years professional experience in Quality Assurance preferred
  • 3 years of experience in a healthcare setting required
  • Knowledgeable of FDA (GMP/GTP regulations), CLIA, OSHA, and DPH regulations
  • Knowledgeable of FACT, JC, and AABB accreditation standards

Work Rights

Not specified

Tailored Resume

Cover Letter