Quality Engineer I, Biologics Analytical Services

Catalent

Review quality investigations including oos and deviations
Experience with fda gmp and iso standards
Ownership of quality sub-systems
The role involves reviewing and managing quality investigations such as Out-of-Specification results and deviations to ensure patient safety

Job Summary

  • The role involves reviewing and managing quality investigations such as Out-of-Specification results and deviations to ensure patient safety.
  • Catalent is a leading global contract development and manufacturing organization supporting the launch of over a hundred new products annually.
  • Candidates will receive competitive medical benefits, 401K, 152 hours of PTO, and 8 paid holidays.

Matching Summary

The role involves reviewing and managing quality investigations such as Out-of-Specification results and deviations to ensure patient safety.

Skills & Requirements

Must-have

  • Review quality investigations including OOS and deviations
  • Experience with FDA GMP and ISO standards
  • Ownership of Quality sub-systems
  • Collaborate with cross-functional teams for CAPAs
  • Ensure inspection readiness for regulatory agencies

Nice-to-have

  • Excellent problem-solving skills
  • Ability to reprioritize projects quickly
  • Strong organizational and communication skills
  • Dynamic fast-paced work environment experience

Key Requirements

  • BS or BA in Related Field
  • 3+ years Scientific or QA/QC Experience
  • Experience in regulated industry and laboratory analysis

Work Rights

Not specified

Tailored Resume

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