Base: $94,000 - $111,000; bonus/equity: not specif...
On-site
Manage deviations and investigations
Manage capas and change controls
Handle product technical complaints
The Senior Quality Associate position at Century Center in Waltham, MA, focuses on managing quality compliance and support throughout the development and manufacturing of investigational medicinal products. The role requires expertise in GMP regulations, deviation management, and quality assurance processes, while offering a collaborative and inclusive work environment
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 role ensures compliance with GMP/GSP/GxP by providing front-line quality guidance and support across all phases of Technical Product Development.
Key responsibilities include managing deviations, facilitating change panel meetings, handling product technical complaints, conducting self-inspections, and providing training in QMS principles.
Matching Summary
Match Score: 85
The Senior Quality Associate position at Century Center in Waltham, MA, focuses on managing quality compliance and support throughout the development and manufacturing of investigational medicinal products. The role requires expertise in GMP regulations, deviation management, and quality assurance processes, while offering a collaborative and inclusive work environment.
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
Handle product technical complaints
Ensure GMP/GSP/GxP compliance
Conduct self-inspections
Provide quality guidance and support
Nice-to-have
Strong customer focus
Team-oriented approach
Ability to self-motivate
Key Requirements
Degree in a 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 Production, Quality, or R&D experience within the Pharmaceutical industry
Sound knowledge of processes for Clinical Trial GMP Manufacture