Forge Biologics, a gene therapy development engine, is seeking a Quality Assurance Specialist to ensure compliance with quality standards in the manufacture of gene therapies. The ideal candidate will have experience in GMP environments and strong regulatory knowledge.
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Skills
Strong understanding of pharmaceutical cGMP requirements
Ability to conduct root cause analysis and investigations
Knowledge of regulatory guidelines (FDA, EU)
Experience in a GxP environment
Responsibilities
Issuance and review of controlled documentation
Review of batch documentation for compliance
Implementation of continuous improvement initiatives
Authoring and approval of investigations and corrective actions
Supporting internal and external audits
Education
Bachelor's Degree in scientific-related field or engineering
Benefits
Health, Dental, and Vision insurance with 90% premiums covered
Flexible PTO and annual bonus
401(K) company match and parental leave
Fully-stocked kitchen and wellness benefits
Professional & personal development resources
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