Base: $94,000 - $111,000; bonus/equity: not specif...
On-site
Manage deviations and investigations
Manage capas and change controls
Product technical complaints management
CSL Seqirus is seeking a Senior Quality Associate in Waltham, MA, responsible for managing quality assurance activities related to the development and manufacture of Investigational Medicinal Products. The role requires expertise in GMP compliance, deviation management, and quality oversight, along with strong interpersonal 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 role ensures compliance with GMP/GSP/GxP by providing front-line quality guidance and support across all phases of Technical Product Development.
This 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
Match Score: 85
CSL Seqirus is seeking a Senior Quality Associate in Waltham, MA, responsible for managing quality assurance activities related to the development and manufacture of Investigational Medicinal Products. The role requires expertise in GMP compliance, deviation management, and quality oversight, along with strong interpersonal 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
GMP/GSP/GxP compliance
Self-inspections and follow-up
Quality Risk Assessments (QRAs)
Nice-to-have
Interpersonal and negotiation skills
Customer focus
Team-oriented
Key Requirements
Degree in biological science
3+ years experience in GMP manufacturing, Regulatory Affairs, QA, or Process Development