Analyst III, Quality Control

Kincell Bio is seeking a highly motivated QC Analyst III who will be a key contributor to a dynamic and collaborative Quality Control team. The Quality Control Analyst III will primarily be responsible for supporting and leading early/late phase and commercial quality control activities.

Requirements

• Actively participate in fostering a positive, collaborative work culture.
• Author and revise standard operating procedures, test methods, protocols, and reports.
• Lead in execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
• Assist in the transfer of assays from the Analytical Development Lab to the QC Lab.
• Demonstrate proficiency in flow cytometric, automated cell counting, dPCR, qPCR, FTIR, ELISA-based, multiplex cytokine detection, pH, endotoxin, and cell-based assays.
• Ensure QC deliverables are met in a timely manner.
• Perform data analysis and review.
• Initiate and participate in laboratory investigations including deviations and out of specifications.
• Perform equipment calibrations.
• Execute method and equipment troubleshooting and optimization, as needed.
• Maintain documentation in accordance with GDP.
• Train and cross train QC personnel on standard operating lab procedures and test methods.

Benefits

• Competitive benefits