Qa Shop Floor Specialist Ii

Legend Biotech

Raritan, New Jersey, United States
On-site
Cgmp compliance knowledge
Aseptic manufacturing experience
Cleanroom gowning proficiency
Legend Biotech is seeking a QA Shop Floor Specialist to oversee quality assurance for the production of autologous CAR-T products in a cGMP cleanroom environment. The role emphasizes compliance with regulations and quality standards while collaborating with manufacturing teams to resolve quality issues

Job Summary

  • The QA Shop Floor Specialist provides quality oversight for the production of autologous CAR-T products in a controlled cGMP cleanroom environment.
  • This role requires supporting manufacturing activities through spot checks, internal audits, and ensuring sterility during aseptic process simulations.
  • Candidates must possess visual acuity of at least 20/30 and color perception capabilities to handle biological materials and hazardous chemicals safely.

Matching Summary

Match Score: 85

Legend Biotech is seeking a QA Shop Floor Specialist to oversee quality assurance for the production of autologous CAR-T products in a cGMP cleanroom environment. The role emphasizes compliance with regulations and quality standards while collaborating with manufacturing teams to resolve quality issues.

Skills & Requirements

Must-have

  • cGMP compliance knowledge
  • aseptic manufacturing experience
  • cleanroom gowning proficiency
  • SAP system usage
  • batch record review skills
  • Good Documentation Practices

Nice-to-have

  • cross-functional collaboration
  • continuous improvement mindset
  • regulatory inspection support
  • investigation team participation

Key Requirements

  • Bachelor's degree in Life Sciences or Engineering
  • 0-2+ years Biotech/Pharmaceutical experience
  • Experience in aseptic manufacturing facility
  • Visual acuity 20/30 with or without correction
  • Color perception test score of 5 out of 8

Work Rights

Not specified

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