Senior Specialist, Operation, Qa For Manufacturing

Trzdev15

On-site with potential off-hours oversight and travel to vendors/cmos as needed.
Gmp compliance experience
Quality risk assessments
Deviation investigation expertise
Trzdev15 is seeking a Senior Specialist in Operations and Quality Assurance for Manufacturing, focusing on ensuring compliance with GMP requirements in the production of cell therapy products. The ideal candidate should have over five years of experience in GMP environments, particularly in cell therapy or biologics, and possess strong technical knowledge in aseptic processing and quality management systems

Job Summary

  • The role focuses on quality oversight for cell therapy products to ensure compliance with GMP requirements.
  • The position involves leading quality professionals and participating in project teams for problem solving.
  • Candidates are expected to proactively contribute to continuous improvement initiatives within the organization.

Matching Summary

Match Score: 85

Trzdev15 is seeking a Senior Specialist in Operations and Quality Assurance for Manufacturing, focusing on ensuring compliance with GMP requirements in the production of cell therapy products. The ideal candidate should have over five years of experience in GMP environments, particularly in cell therapy or biologics, and possess strong technical knowledge in aseptic processing and quality management systems.

Skills & Requirements

Must-have

  • GMP compliance experience
  • Quality Risk Assessments
  • Deviation Investigation expertise

Nice-to-have

  • Continuous improvement mindset
  • Strong interpersonal skills
  • Project management experience

Key Requirements

  • Bachelor’s degree in Life Sciences
  • 5+ years in GMP cell therapy
  • Familiarity with US FDA guidance

Work Rights

Not specified

Tailored Resume

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