Senior Quality Associate

CSL Behring

$94,000 - $111,000 py
Not specified (suggested to clarify with the employer)
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 quality-related processes in the development of Investigational Medicinal Products. The role emphasizes ensuring compliance with GMP regulations, managing deviations, and providing quality support throughout technical product development

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 involves educating technical staff in GxP and quality system requirements and establishing local and global product related Quality Agreements.

Matching Summary

Match Score: 85

CSL Behring is seeking a Senior Quality Associate responsible for managing quality-related processes in the development of Investigational Medicinal Products. The role emphasizes ensuring compliance with GMP regulations, managing deviations, and providing quality support throughout technical product development.

Salary

$94,000 - $111,000

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

  • Interpersonal and influencing skills
  • Customer focus and team orientation
  • Ability to work independently

Key Requirements

  • At least 3 years experience in manufacturing under GMP, Regulatory Affairs, Quality Assurance or Process Development
  • Degree in a relevant biological science
  • In-depth understanding of GMP requirements
  • Previous Production, Quality or R&D experience within the Pharmaceutical industry
  • Knowledge of Clinical Trial GMP Manufacture processes

Work Rights

Not specified

Tailored Resume

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