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Senior Quality Assurance Engineer
2 months ago
We are seeking a highly skilled Quality Assurance Senior Engineer to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and compliance of our manufacturing processes and products.
Key Responsibilities- Partner with cross-functional teams to ensure quality oversight of drug product processes, including formulation, fill, and inspection.
- Generate, review, and approve QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in a cGMP regulated facility.
- Perform other duties as assigned.
- Bachelor's degree in Life Sciences or Engineering with 9+ years of applicable industry experience.
- OR Master's degree in Life Sciences or Engineering and 6+ years of applicable experience.
- OR PhD in Life Sciences or Engineering and 3+ years of applicable experience.
- 5+ years of experience in GMP Quality Assurance and/or similar role.
- Experience in Validation, cGMP manufacturing operations, and/or Quality oversight in an FDA regulated facility.
- Prior experience of one or more of the following processes: formulation, aseptic filling, automated visual inspection, and finished goods manufacturing.
- Prior experience and knowledge with Quality Risk Management Principles.
- Advanced understanding of cell culture, upstream processes, large scale recovery, and/or downstream processes.
- Expertise in cGMP & FDA regulations.
- Experience with startup projects or initiatives.
The ideal candidate will have excellent communication and problem-solving skills, with the ability to work in a fast-paced environment. Occasional travel may be required.
FUJIFILM Diosynth Biotechnologies is an Equal Opportunity Employer. We are committed to diversity and inclusion in the workplace.
