Gene Therapy Quality Assurance Specialist
1 week ago
We are seeking a highly skilled Quality Engineer I to join our team at Forge Biologics. This individual will work closely with cross-functional teams to provide quality oversight, review, and approval of engineering, validation, and quality system deliverables.
Key Responsibilities- Review and approval of calibration and preventive maintenance events within a Computerized Maintenance Management System (CMMS).
- Review and approval of validation documents across validation disciplines developed by functional validation teams.
- Initiate and update risk assessments on systems and processes.
- Perform risk analysis and failure prevention analysis.
- Support early-stage process validation activities, including Tech Transfer and Quality by Design.
- Provide analytics and statistical process control support to quality and operations.
- Support quality investigations, CAPAs, continuous improvement, and change controls.
- Assist with resolving issues arising from internal quality assessments/audits and regulatory inspections.
- Support internal and external audits from a quality engineering and validation perspective.
- Employ Good Document Practices (GDP) when recording data, maintaining archives, and drafting and reviewing documents.
- Bachelor's Degree in Engineering, Science, or equivalent technical background.
- Experience working in a GMP environment with Quality Management Systems.
- Working knowledge of cGMPs, ISPE Guidelines, Data Integrity, 21 CFR Part 11, and Annex 11 Regulations.
- Strong attention to detail, organization, and proactive mindset.
- Excellent verbal and written communication skills.
- Ability to meet deadlines and use critical thinking skills to problem-solve effectively.
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Gene Therapy Quality Assurance Specialist
7 days ago
Columbus, Ohio, United States Forge Biologics Full timeAbout Forge BiologicsForge Biologics is a gene therapy development engine that enables access to life-changing medicines. We partner with innovators in the gene therapy community, leveraging expertise in manufacturing and therapeutics development to bring transformative treatments from idea to reality.
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Gene Therapy Development Specialist
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Columbus, Ohio, United States Forge Biologics Full timeJob Title: Gene Therapy Manufacturing SpecialistCompany OverviewForge Biologics is a leading gene therapy development engine, focused on enabling access to life-changing treatments. We partner with innovators in the gene therapy community, bringing expertise in manufacturing and therapeutics development to help champion teams from idea to reality.Estimated...
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Gene Therapy Manufacturing Specialist
3 days ago
Columbus, Ohio, United States Forge Biologics Full timeJob OverviewForge Biologics is a leading gene therapy development engine, dedicated to enabling access to life-changing treatments. We partner with innovators in the gene therapy community, providing expertise in manufacturing and therapeutics development.
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Gene Therapy Manufacturing Specialist
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