Scientist II, QC Virology Specialist

4 days ago


Holly Springs, Georgia, United States Fujifilm Corporation Full time
About the Role

The QC Virology Scientist II is a technical subject matter expert responsible for ensuring GMP compliant laboratory operations in accordance with regulatory guidelines. This role will perform technical/compliance reviews and approve analytical results, as well as approve laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs).

Key Responsibilities
  • Perform analytical methods that require aseptic techniques, including viral infectivity assays, qPCR assays, 28-day and 14-day Adventitious Agent assays, growth and purification of viral stocks, titering of viral stocks, and cell culture maintenance.
  • Ensure analytical testing of in-process samples are performed according to appropriate GMP regulations.
  • Perform laboratory work and peer reviews of analytical data in support of tech transfer and routine manufacturing.
  • Execute and review method qualification, and validation activities, and maintain lab equipment.
  • Monitor assay performance and implement improvements that ensure quality and efficiency within QC Virology.
  • Troubleshoot and investigate deviations and invalid assays performed in QC Virology.
  • Author, review, and approve SOPs, protocols, reports, change controls, Trackwise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Bioassay/Virology team, as needed.
  • Perform viral risk assessments for incoming new raw materials and document assessment in a technical report as part of change management.
  • Represent QC Virology in cross-functional collaborations with QC Analytical Development, QC Program Management, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives.
  • Manage and monitor lab activities as needed.
  • Provide training for QC Virology associates.
  • Provide technical support as the QC Virology SME during customer visits, audits, and regulatory inspections.
  • Participate in risk and gap assessments during project scoping as needed.
  • Collaborate with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements.
  • Liaise with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results as needed.
Requirements
  • B.S. in Microbiology, Virology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9+ years of experience.
  • 9+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO).
  • 4-6 years experience in a GMP environment.
Preferred Requirements
  • M.S. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6+ years of experience, OR Ph.D. in Virology, Microbiology, Biology, Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience.
  • Experience working in a Virology lab in a GMP Environment.
  • Experience troubleshooting viral infectivity assays, growing viral stock, growing and cryofreezing cell banks stocks.
  • Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system).
Physical and Work Environment Requirements

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

Ability to conduct activities using repetitive motions that include writs, hands, and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments.



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