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Virology Quality Control Scientist II
2 months ago
Overview
Join a Leading Life Science Manufacturing Organization
At Fujifilm Corporation, we are committed to advancing healthcare through innovative biopharmaceutical manufacturing. We are expanding our operations and seeking dedicated professionals who are passionate about making a significant impact in the field of life sciences.
About the Role
The Virology Quality Control Scientist II plays a crucial role as a technical expert in the Quality Control (QC) department. This position is responsible for overseeing analytical methods that require aseptic techniques, including viral infectivity assays, mammalian cell culture, and the purification of viral stocks. The Scientist will ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards while performing technical reviews and approving analytical results.
Key Responsibilities
- Conduct analytical methods requiring aseptic techniques, including viral infectivity assays and qPCR assays.
- Ensure that all analytical testing of in-process samples adheres to GMP regulations.
- Engage in laboratory work and peer reviews to support technology transfer and routine manufacturing processes.
- Oversee method qualification and validation activities while maintaining laboratory equipment.
- Monitor assay performance and implement enhancements to improve quality and efficiency within the QC Virology team.
- Investigate deviations and invalid assays, providing troubleshooting support as necessary.
- Author and review Standard Operating Procedures (SOPs), protocols, and technical reports.
- Perform viral risk assessments for new raw materials and document findings in technical reports.
- Collaborate with cross-functional teams to achieve organizational objectives.
- Provide training and mentorship to QC Virology associates.
- Support technical inquiries during audits and regulatory inspections.
- Work closely with IT and LIMS teams to enhance method functionalities.
- Coordinate with Contract Laboratory Organizations (CLOs) to ensure timely execution of methods and delivery of results.
Minimum Qualifications:
- Bachelor's degree in Microbiology, Virology, Biology, Chemistry, Biochemistry, or a related field with a minimum of 9 years of relevant experience.
- Extensive analytical laboratory experience, preferably in biotechnology or pharmaceutical environments.
- Experience in a GMP setting for at least 4-6 years.
Preferred Qualifications:
- Master's or Ph.D. in a relevant scientific discipline with applicable experience.
- Proven experience in a Virology laboratory within a GMP environment.
- Familiarity with quality systems and deviation management processes.
Physical and Work Environment Requirements:
Candidates must possess the ability to perform tasks requiring visual acuity, including color differentiation, and the capacity to stand or sit for extended periods. The role may involve repetitive motions and the ability to lift objects up to 10 pounds.
Fujifilm Corporation is an Equal Opportunity Employer. We welcome applications from all qualified individuals without regard to race, color, religion, sex, national origin, disability, or any other protected status.
