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
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CSL Behring is seeking a Senior Quality Associate in Waltham, MA, responsible for managing compliance-related activities in the development and manufacturing of investigational medicinal products. The ideal candidate should have a degree in a relevant biological science and at least three years of experience in GMP, Regulatory Affairs, or Quality Assurance within the pharmaceutical industry.
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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.
This role 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: 75
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CSL Behring is seeking a Senior Quality Associate in Waltham, MA, responsible for managing compliance-related activities in the development and manufacturing of investigational medicinal products. The ideal candidate should have a degree in a relevant biological science and at least three years of experience in GMP, Regulatory Affairs, or Quality Assurance within the pharmaceutical industry.
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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
GMP/GSP/GxP compliance
conduct self-inspections
Nice-to-have
quality guidance and support
customer focus
team oriented
interpersonal and negotiation skills
Key Requirements
Degree in biological science
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