QC Manager, Bioassay/Virology Specialist

2 days ago


Holly Springs, Georgia, United States FUJIFILM Corporation Full time
About This Role

The Manager, Bioassay/Virology is a key member of the Quality Control team at FUJIFILM Diosynth Biotechnologies. This role is responsible for leading the Bioassay and Virology team in ensuring the quality and integrity of our products. The successful candidate will have a strong background in bioassay and virology testing methods and experience in a GMP environment.

Key Responsibilities
  • Ensure GMP compliant laboratory operations according to regulatory guidelines
  • Manage the daily activities of the QC Bioassay and Virology team, prioritizing work and ensuring timely analysis and review of results
  • Oversee and manage laboratory exceptions and investigations, ensuring timely closure within the group
  • Lead projects, such as method transfers and method qualifications, in support of new product introduction for new and existing customers
  • Develop and implement optimized laboratory systems, including the use of IT systems, to improve efficiency and reduce turn-around-times
  • Ensure the department is ready for customer visits, audits, and regulatory inspections
Requirements
  • Bachelor's degree with 8+ years of experience in a GMP environment OR Master's Degree with 6+ years of experience in GMP environment OR Ph.D. with 4+ years of experience in GMP environment
  • Previous QC Bioassay and Virology leadership experience
  • Advanced knowledge in Bioassay and Virology testing methods
Working Conditions and Physical Requirements

The successful candidate will be required to work in a fast-paced laboratory environment, with the ability to stand for prolonged periods of time and conduct activities using repetitive motions. The ability to work in environments between -20 and -70 C for a few minutes with appropriate PPE is also required.



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