Quality Assurance Coordinator in Analytical Development Lead
12 hours ago
We are seeking a highly skilled Senior Quality Assurance Coordinator to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our Analytical Development team, you will be responsible for overseeing method transfer activities, leading collaborative meetings with customers and internal stakeholders, and ensuring timely completion of projects.
About the Position
The successful candidate will have a Master of Science degree in a relevant field, experience with cGMP QC laboratory practices, pharmacopoeias, and ICH guidelines, as well as strong project management skills. They will also possess excellent communication and collaboration skills, with the ability to ensure engagement, motivation, and recognition of multiple stakeholders.
Key Responsibilities
- Lead collaborative meetings with customers and internal stakeholders to prioritize method transfer activities and ensure timely completion of projects
- Develop and implement transfer plans, generate transfer summary reports, and manage change control processes
- Review and approve transfer/validation/qualification protocols and reports
- Contribute to optimization projects supporting best Tech Transfer practices
Qualifications and Education
- Master of Science degree in Pharmaceutical Sciences, Biochemistry, Protein Chemistry, Biology, or similar relevant education
- Experience with cGMP QC laboratory practices, pharmacopoeias, and ICH guidelines
- Strong project management skills and experience with method transfer and validation
- Documented ability to ensure strong stakeholder focus and adapt to business needs
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