Senior Quality Associate

CSL

Waltham, MA, United States
Base: $94,000 - $111,000; bonus/equity: incentive ...
On-site
Gmp/gsp/gxp compliance
Deviation management
Capa management
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 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

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: Incentive compensation and equity may be included; Benefits: Not specified

Skills & Requirements

Must-have

  • GMP/GSP/GxP compliance
  • Deviation management
  • CAPA management
  • Change control management
  • Product technical complaints

Nice-to-have

  • Interpersonal skills
  • Negotiation skills
  • Influencing skills
  • Customer focus
  • Team oriented

Key Requirements

  • At least 3 years of experience
  • Degree in relevant biological science
  • In-depth understanding of GMP
  • Previous Production, Quality or R&D experience

Work Rights

Not specified

Tailored Resume

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