Senior Quality Specialist

Catalent

San Diego, California, US
Base: $92,000 to $102,000 annually; bonus/equity: ...
10+ years quality assurance experience
Gmp manufacturing environment expertise
Batch record review and deviation investigation
The Senior QA Specialist supports clinical trial projects ensuring all work is performed in compliance with regulatory requirements and cGMP standards

Job Summary

  • The Senior QA Specialist supports clinical trial projects ensuring all work is performed in compliance with regulatory requirements and cGMP standards.
  • Catalent's San Diego facility focuses on early-stage development of small molecule and peptide drug candidates using advanced spray drying technologies.
  • Employees enjoy competitive benefits including medical, dental, vision effective day one, 152 hours of PTO plus 10 paid holidays, and a generous 401K match.

Matching Summary

The Senior QA Specialist supports clinical trial projects ensuring all work is performed in compliance with regulatory requirements and cGMP standards.

Salary

Base: $92,000 to $102,000 annually; Bonus/Equity: Potential for bonus; Benefits: Medical, dental, vision, 401K match, 152 hours PTO + 10 holidays

Skills & Requirements

Must-have

  • 10+ years Quality Assurance experience
  • GMP manufacturing environment expertise
  • Batch record review and deviation investigation

Nice-to-have

  • Six Sigma or ASQ certification preferred
  • Strong MS Office and Excel skills
  • Data integrity validation knowledge

Key Requirements

  • HS Diploma or GED required
  • Bachelor's or Master's degree in scientific field preferred
  • 10+ years of QA experience in GMP manufacturing

Work Rights

Not specified

Tailored Resume

Cover Letter