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eGenesis
Cambridge, MA
Source: eGenesis careers · View original posting
From eGenesis's posting. “We” and “our” refer to the employer.
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH.
eGenesis is headquartered in Cambridge, MA.
At eGenesis, our core values
—innovation, collaboration, compassion, resilience, and passion—are at the center of how we work. We engineer hope and bring passion to everything we do. We collaborate and learn from one another, combining diverse expertise to tackle complex challenges. We innovate boldly, pushing boundaries and science to new heights. where no pig organ has gone before. With resilience, we navigate challenges and celebrate progress together. And in all we do, we lead with compassion—for our patients, our people, and our pigs.
POSITION SUMMARY
The Senior Quality Systems Specialist will be supporting the QA team to implement and manage Quality Systems supporting GMP Manufacturing and Testing across all eGenesis locations.
This position reports to the Associate Director of Quality Systems and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization. This position will be in Cambridge, MA.
Implement process improvements to enhance compliance and improve method and product quality processes (e.g. process tools creation, SOP revision, or enterprise systems implementation)
Provide Quality Assurance support in reviewing/approving executed records in needed areas (Forms, Logbooks, Master Batch Records etc.)
Perform duties regarding special projects, as assigned by QA Management
TECHNICAL QUALIFICATIONS: Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management
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