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  • Location: Cambridge
  • Salary: Competitive Salary with benefits & progression opportunities
  • Job Type:Permanent

Posted 24 days ago

  • Sector: Quality
  • Contact: Nicole Cooper
  • Contact Email: nicole.cooper@nextphaserecruitment.com
  • Contact Phone: 01403 216216
  • Job Ref: QA Assistant - 52068

Do you want to be involved in supporting the development of cutting-edge and breakthrough therapies? A steadily growing CDMO have opportunity for an experienced QA officer to join them on-site on a permanent basis.

What you’ll be doing

  • Writing and reviewing quality documents, SOPs and other policies

  • Supporting with QMS activities including issuing validation plans and performing risk assessments

  • Support all departments with writing and assessing change controls, non-conformances, root-cause analysis, risk assessments and CAPAs

  • Support with internal and external audits and other regulatory inspections

  • Develop and implement training materials and sessions in-house

What we need from you

  • Proven experience in cellular and/or gene therapies working in a QA role, preferably within a GMP environment

  • Experience in writing QA documents, particularly SOPs

  • Experience performing and managing risk assessments

  • Experience with internal auditing as well as managing deviations, non-conformances and CAPAs

  • Understanding of cell and gene therapies

  • A BSc in life sciences, or comparable experience

What’s on offer

  • Competitive salary

  • Additional benefits 

  • Excellent opportunities for growth and personal development

  • Progression opportunities