Senior Quality Associate

cslbehring.de

Base: $94,000 - $111,000; bonus/equity: may includ...
Not specified
Manage deviations and investigations
Manage capas and change controls
Ensure gmp/gsp/gxp compliance
CSL Behring is seeking a Senior Quality Associate responsible for managing deviations, investigations, and compliance in the development of Investigational Medicinal Products. The role requires a solid understanding of GMP regulations and offers a competitive salary, along with a commitment to inclusivity and employee well-being

Job Summary

  • The Sr. Quality Associate is responsible for managing deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product.
  • This role provides front-line quality guidance and support across all phases of Technical Product Development, ensuring compliance with GMP/GSP/GxP.
  • The position requires a degree in a relevant biological science with at least 3 years of experience in manufacturing under GMP, Regulatory Affairs, Quality Assurance, or relevant Process Development.

Matching Summary

Match Score: 85

CSL Behring is seeking a Senior Quality Associate responsible for managing deviations, investigations, and compliance in the development of Investigational Medicinal Products. The role requires a solid understanding of GMP regulations and offers a competitive salary, along with a commitment to inclusivity and employee well-being.

Salary

Base: $94,000 - $111,000; Bonus/Equity: May include incentive compensation and equity; Benefits: Not specified

Skills & Requirements

Must-have

  • Manage deviations and investigations
  • Manage CAPAs and change controls
  • Ensure GMP/GSP/GxP compliance
  • Product technical complaint management
  • Conduct self-inspections

Nice-to-have

  • Customer focus
  • Team oriented
  • Ability to work independently

Key Requirements

  • At least 3 years experience in GMP manufacturing, Regulatory Affairs, QA, or Process Development
  • In-depth understanding of GMP requirements
  • Previous Production, Quality or R&D experience in Pharmaceutical industry
  • Sound knowledge of Clinical Trial GMP Manufacture processes

Work Rights

Not specified

Tailored Resume

Cover Letter