Senior Quality Associate

VacaturesInFarma

Waltham, MA, United States
Base: $94,000 - $111,000; bonus/equity: not specif...
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Manage deviations and investigations
Manage capas and change controls
Product technical complaints management
** CSL Behring is seeking a Senior Quality Associate in Waltham, MA, responsible for managing quality assurance processes related to the development and manufacturing of investigational medicinal products. The ideal candidate should have a background in the pharmaceutical industry, particularly in GMP compliance, and possess strong analytical and communication skills. **

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.
  • The primary purpose is ensuring compliance with GMP/GSP/GxP by providing front-line quality guidance and support across all phases of Technical Product Development.
  • Key responsibilities include participating in IPT meetings, managing deviations and change controls, conducting self-inspections, and providing training in QMS principles.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Senior Quality Associate in Waltham, MA, responsible for managing quality assurance processes related to the development and manufacturing of investigational medicinal products. The ideal candidate should have a background in the pharmaceutical industry, particularly in GMP compliance, and possess strong analytical and communication skills. **

Salary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Team oriented
  • Strong customer focus
  • Ability to relate and communicate
  • Continuous improvement initiatives

Key Requirements

  • Degree in relevant biological science
  • At least 3 years experience in manufacturing under GMP, Regulatory Affairs, Quality Assurance, or Process Development
  • In-depth understanding of GMP requirements
  • Previous Pharmaceutical industry experience
  • Sound knowledge of Clinical Trial GMP Manufacture processes

Work Rights

Not specified

Tailored Resume

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