Senior Quality Associate - Preclinical & Laboratory Quality

Century Center

Base: $94,000 - $111,000; bonus/equity: incentive ...
Knowledge of oecd principles of glp
Experience with iso/iec 17025 requirements
Minimum 3 years in glp/gxp laboratory qa
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D functions

Job Summary

  • This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D functions.
  • The position involves leading inspection readiness activities, managing regulatory inspections, and overseeing corrective and preventive actions to ensure timely resolution of findings.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture of inclusion and belonging at its core.

Matching Summary

This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D functions.

Salary

Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Must-have

  • Knowledge of OECD Principles of GLP
  • Experience with ISO/IEC 17025 requirements
  • Minimum 3 years in GLP/GxP laboratory QA
  • Ability to review study protocols and reports
  • Experience managing regulatory inspections

Nice-to-have

  • Strong planning and organizational skills
  • Commitment to continuous improvement
  • Good presentation and negotiation skills
  • Customer focus in R&D partnerships
  • Ability to model CSL Way values

Key Requirements

  • BS Degree in biological science or related discipline
  • Minimum 3 years experience in GLP/GxP conditions
  • Knowledge of Quality Systems application
  • Experience in R&D Quality or product development

Work Rights

Not specified

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