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Quality Assurance Consultant

Job ID: 214649

Location: New York, New York , US, 10001

Summary:

Perform tactical work and review a variety of documents, protocols, and reports.

Project Details:

  • Exhibit varying levels of experience and a solid progression of work and/or training
  • Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies
  • Review and approve manufacturing records, change controls, investigations and analytical data
  • Review and approve test methods and method validations
  • Review manufacturing validation protocol and reports

Job Experience:

  • Experience in small molecule manufacturing and contract manufacturing
  • Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline
  • A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
  • Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc.
  • Excellent verbal and written communication skills
  • Demonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
  • Strong analytical skills
  • Effective project management and organizational skills are essential
  • Knowledge and understanding of quality
  • Manufacturing processes and procedures, planning, supply chain, inventory management

Hourly Rate: 31.875-41.25

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