Senior Quality Assurance Consultant

2 days ago


Houston, TX, United States JCW Group Full time

Our pharmaceutical client is seeking a Senior QA Consultant with deep expertise in sterility assurance, aseptic processing, and contamination control. This role focuses on driving GMP remediation efforts following recent regulatory observations.

Responsibilities
  • Lead sterility-related quality remediation across aseptic manufacturing and utilities
  • Strengthen contamination control strategies, environmental monitoring programs, and cleanroom practices
  • Review and upgrade SOPs, deviation/CAPA systems, and batch record processes
  • Provide QA oversight on validation, change control, and inspection readiness
Qualifications
  • 10+ years of experience in QA for sterile or aseptic manufacturing
  • Proven success in regulatory remediation or inspection response projects
  • Expert knowledge of GMP, Annex 1, and sterility assurance principles
  • Strong communicator and strategic problem solver

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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