Quality Control

Quality Control

Position Overview

Quality Control supports manufacturing, validation, process development, and stability studies by performing analytical testing and sampling in a GMP-regulated environment. This role also leads and coordinates filled visual inspections for product lot release while ensuring strict adherence to established analytical methods and quality standards.

Key Responsibilities

• Perform and review routine cell maintenance and cell-based assays (e.g., TCID50), ELISA, electrophoresis (SDS-PAGE), immunoblotting, HPLC, and qPCR to support testing and characterization of viral vector products.
• Conduct aseptic sampling, visual inspection, and routine analytical testing, including pH, conductivity, osmolality, and spectrophotometry.
• Review, revise, and author analytical test methods and standard operating procedures (SOPs).
• Support validation efforts, investigations, and method development projects as needed.
• Prepare study protocols, reports, and technical documentation.
• Train and mentor other QC analysts.
• Collaborate cross-functionally to develop, revise, and implement QC procedures and policies.
• Maintain knowledge of company cGMPs and applicable regulatory requirements.
• Participate in regulatory inspections and audits.
• Support continuous improvement initiatives within the Quality Control department.
• Perform other duties as assigned.

Minimum Qualifications

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or a related scientific discipline.
• Minimum of two years of hands-on experience working with viral vectors or in a BSL-2 laboratory environment.
• Experience with analytical testing methods and equipment, GMP documentation, SOP/report writing, and regulatory audits.

Work Schedule

This is a full-time position, operating Monday through Friday. The role may require overtime and/or weekend work as business needs dictate.

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