GMP Quality Assurance Specialist
2 weeks ago
Company Overview
Forge Biologics is at the forefront of gene therapy innovation, dedicated to developing transformative therapies for patients in need. As part of Ajinomoto Bio-Pharma Services, we work collaboratively with key stakeholders in the gene therapy sector to bring groundbreaking medicines from concept to reality. Our commitment to patient care drives us to accelerate the availability of these vital therapies. Our advanced facility serves as a center for AAV manufacturing and pioneering therapeutic development.
Role Overview
The Quality Assurance Specialist is essential in maintaining compliance and operational excellence within the Forge GMP facility. Key responsibilities include managing controlled documentation issuance, reviewing batch records, verifying manufacturing activities, creating and reviewing SOPs, conducting investigations, and implementing CAPAs. The successful candidate will demonstrate excellent communication skills, a sense of accountability, and a collaborative spirit within the QA team.
Key Responsibilities
- Serve as a quality resource during GMP manufacturing processes
- Review and issue controlled documents, including SOPs and batch records
- Conduct thorough reviews of batch documentation to ensure compliance and adherence to best practices
- Promote continuous improvement through proactive quality enhancement initiatives
- Assist in investigations, CAPAs, and change controls with a focus on root cause analysis
- Engage in internal and external audits as necessary
Qualifications
- Bachelor's Degree in a scientific discipline or equivalent experience
- Knowledgeable in Good Documentation Practices and GxP environments
- Familiar with cGMP regulations and FDA/EU standards
- Exceptional attention to detail and ability to manage multiple tasks in a dynamic environment
- Experience working in aseptic settings and applying aseptic techniques
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