Senior Specialist, Quality Operations

Catalent

Princeton, New Jersey, United States
Base: $110,000 - $125,000; bonus/equity: annual bo...
Bachelor of science in life sciences
7 years biologic or regulated industry experience
Proficiency in cgmp regulations and batch disposition
The Senior Specialist provides advanced Quality oversight for GMP documentation and ensures compliance with regulations for cell therapy products

Job Summary

  • The Senior Specialist provides advanced Quality oversight for GMP documentation and ensures compliance with regulations for cell therapy products.
  • Candidates will serve as the dedicated Client QA Representative, partnering with cross-functional teams to maintain site compliance and drive continuous improvement.
  • The role offers a competitive salary range of $110,000 - $125,000 plus annual bonus, along with comprehensive benefits including 152 hours of paid time off.

Matching Summary

The Senior Specialist provides advanced Quality oversight for GMP documentation and ensures compliance with regulations for cell therapy products.

Salary

Base: $110,000 - $125,000; Bonus/Equity: Annual bonus when eligible; Benefits: Medical, dental, vision, 401K, 152 PTO hours, tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor of Science in Life Sciences
  • 7 years biologic or regulated industry experience
  • Proficiency in cGMP regulations and batch disposition

Nice-to-have

  • Master of Science degree preferred
  • Auditor certification (CQA) is a plus
  • Experience with electronic document management systems

Key Requirements

  • Minimum 7 years experience in biologic/biopharmaceutical industry
  • Bachelor's degree required; Master's preferred
  • Experience performing cGMP internal and supplier audits

Work Rights

Not specified

Tailored Resume

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