Quality Auditor Ii

Sterigenics (part of Sotera Health)

Glp study review experience
Gmp and iso regulation knowledge
Capa initiation and resolution
The Quality Auditor II reviews GLP studies for completeness, compliance, concurrence, and accuracy while providing regulatory guidance

Job Summary

  • The Quality Auditor II reviews GLP studies for completeness, compliance, concurrence, and accuracy while providing regulatory guidance.
  • This role requires proficient knowledge of quality practices to perform independent investigations and drive process improvements within the team.
  • Candidates must demonstrate a history of successful process improvement implementation and collaborate with Section Leaders and Study Directors.

Matching Summary

The Quality Auditor II reviews GLP studies for completeness, compliance, concurrence, and accuracy while providing regulatory guidance.

Skills & Requirements

Must-have

  • GLP study review experience
  • GMP and ISO regulation knowledge
  • CAPA initiation and resolution
  • Independent decision making
  • Process improvement implementation

Nice-to-have

  • Strong verbal and written communication
  • Public speaking and presentation skills
  • Conflict management abilities
  • Self-motivated initiative
  • Multi-tasking capabilities

Key Requirements

  • A.A. / A.S. with three years NLI laboratory experience
  • B.S. in Microbiology or biological science degree preferred
  • Two years NLI applicable laboratory or quality experience

Work Rights

Not specified

Tailored Resume

Cover Letter