Forge Biologics is seeking a Quality Engineer I to provide quality oversight in gene therapy development. The role involves ensuring regulatory compliance and internal standards, focusing on high-quality gene therapy manufacturing.
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Skills
Quality Management Systems
GMP Environment
Risk Analysis
Strong communication skills
Attention to detail
Responsibilities
Review and approve calibration and preventive maintenance events
Conduct validation document reviews across disciplines
Initiate/update risk assessments on systems and processes
Support early-stage process validation activities
Provide analytics and statistical process control support
Assist with resolving internal quality assessments
Support internal/external audits
Education
Bachelor’s Degree in Engineering or Science
Benefits
Health, Dental, and Vision insurance
Flexible PTO
Annual bonus
401(K) company match
Fully-stocked kitchen
Paid parental leave
Employee Assistance Program
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