Full-Time

Principal Specialist

Quality Assurance Operations

Confirmed live in the last 24 hours

Editas Medicine

Editas Medicine

201-500 employees

Develops CRISPR-based gene editing therapies

Biotechnology

Senior

Cambridge, MA, USA

Requirements
  • Bachelor’s/Master’s in Biology, Chemistry or other life science
  • 8+ years of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment
  • Working knowledge of cGMP requirements in clinical or commercial biologics
  • Understanding of regulatory guidance on cell and gene therapy products
  • Expertise in cGMP compliance and providing GMP documentation
Responsibilities
  • Supporting Quality Operations
  • Providing Quality oversight of start-up activities
  • Reviewing batch records and documentation
  • Supporting QA on the floor activities
  • Authoring, reviewing, and approving GMP documentation
  • Reviewing and approving deviations, change controls, and CAPAs
  • Collaborating with cross-functional teams
  • Handling complex investigations
  • Ensuring compliance to cGMP
  • Maintaining inspection readiness
  • Providing QA oversight for product shipments
  • Assisting in internal and external audits

Editas Medicine is a leader in the biotechnology industry, focused on developing cutting-edge CRISPR gene editing technologies to create transformative medicines for serious diseases. This focus places the company at the forefront of genetic research and therapy development, providing a dynamic and pioneering environment for its employees. As a workplace, it promises a culture of constant learning and innovation, ideal for those passionate about advancing healthcare and contributing to vital medical breakthroughs.

Company Stage

IPO

Total Funding

$884.6M

Headquarters

Cambridge, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

15%

1 year growth

27%

2 year growth

18%