Scientist I, Quality Control

Job Responsibilities

• Conduct assay transfer, qualification, validation, and routine testing for ELISA-based assays, PCR-based assays, and cell-based assays.
• Generate, analyze, and document data with accuracy and compliance to GMP, GDP, and ALCOA+ standards.
• Perform second scientist review on worksheet and electronic data.
• Draft and review analytical method procedures, SOPs, protocols, and reports.
• Perform reagent qualification and cell banking activities.
• Participate in investigation of OOS, deviations, and atypical results; support root cause analysis and CAPA activities.
• Support method lifecycle activities including transfer, qualification, validation, and maintenance.
• Collaborate with cross-functional teams including Analytical Sciences, Manufacturing, and Quality Assurance to ensure timely project delivery.
• Utilize laboratory systems (i.e. LIMS and electronic systems) for data documentation and tracking.
• Support internal audits, client audits, and regulatory inspections as required.
• Support daily lab operation activities, including but not limited to lab equipment cleaning, lab maintenance.
• May be required to work on weekends or during off hours

Job Qualifications

• Bachelor’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 4 years of industry quality control experience.
• Or Master’s degree in Analytical Chemistry, Biochemistry, or related field with a minimum of 2 years of industry quality control experience.
• Hands-on experience with qPCR-based, ELISA-based assay is required.
• Hands-on experience with cell-based assay is required.
• Strong data analysis, organizational, and documentation skills.
• Strong communication and presentation skills.
• A minimum of two years of hands-on experience in qPCR-based, and ELISA-based assay.
• A minimum of one year of hands-on experience in cell-based assay.
• Knowledge in PCR-based, ELISA-based assay principles.
• Knowledge in mammalian cell culture and cell-based assay.
• Understanding of antibody and protein structural characteristics
• Knowledge in large molecule drug development and life cycle management is preferred.
• Ability to adapt to fast-pace working environment
• Ability to adapt to frequent shift in responsibilities.
• Good communication and ability to work in a team-oriented environment.
• Able to be organized and keep positive attitude in high-stress working environment.

Pay

The anticipated pay range for this position is $60,000 - $96,000.