Senior Quality Systems Specialist

Job overview

The Senior Quality Systems Specialist role is onsite in Cambridge, MA. Compensation is not specified. eGenesis is a clinical-stage biotechnology company developing engineered organs to address the global organ shortage. The specialist supports the Quality Assurance team in implementing and managing quality systems for GMP manufacturing and testing. The role helps maintain compliant processes, documentation, training, and quality oversight across company locations and cross-functional teams.

What you'll do

• Develop and maintain QA processes for clinical-study material manufacturing
• manage deviations and CAPAs
• administer the electronic laboratory notebook for batch records and test methods
• manage documentation and training
• report quality metrics
• support cGMP-compliant policies and procedures
• collaborate on manufacturing quality issues
• mentor staff
• review and approve executed records
• support process improvements and special projects.

What we're looking for

Skills & competencies

quality systems

quality assurance

cambridge ma

egenesis

biotechnology

gmp

cgmp

capa

deviation management

document control

training program

quality metrics

electronic laboratory notebook

Work arrangement

• Weekend coverage required

Why this role

Supports quality systems across GMP manufacturing and testing at multiple eGenesis locations.

About the employer

eGenesis is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.