Senior Quality Associate

cslbehring.cz

Base: $94,000 - $111,000; bonus/equity: not specif...
Manage deviations and investigations
Manage capas
Manage product technical complaints
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

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 reports to the Regional Product Development Quality Lead (APAC/EU) and has no direct reports.
  • The expected base salary range for this position at hiring is $94,000 - $111,000.

Matching 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.

Salary

Base: $94,000 - $111,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Manage deviations and investigations
  • Manage CAPAs
  • Manage product technical complaints
  • Manage change controls
  • Ensure GMP/GSP/GxP compliance
  • Conduct self-inspections
  • Provide quality guidance and support

Nice-to-have

  • Strong customer focus
  • Team oriented
  • Ability to work independently

Key Requirements

  • At least 3 years experience in manufacturing under GMP, Regulatory Affairs, Quality Assurance or relevant 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
  • Sound knowledge of processes for Clinical Trial GMP Manufacture

Work Rights

Not specified

Tailored Resume

Cover Letter