Quality Control Analyst

Summary

GeneFab is seeking a Quality Control Analyst I/II to ensure consistent quality of cell manufacturing process by performing laboratory tests, analyzing data, and reviewing GMP documentation. The candidate should have relevant experience and a B.S. degree in biology or related field with 0-3 years (QC Analyst I) or +3 years of industry experience (QC Analyst II).

Requirements

• B.S. degree in biology or related field with experience in cell therapy, immunology, cancer biology, or a closely related field, and 0-3 years (QC Analyst I) or +3 years of industry experience (QC Analyst II)
• Experience with relevant technologies
• Experience with assay development, method qualification, and routine testing in GLP and/or GMP environment
• Proficient in MS Word, Excel, Project, and PowerPoint

Responsibilities

• Successfully execute and document laboratory procedures and experiments with great attention to detail
• Perform QC testing on raw materials, in-process and final product samples
• Assess data to ensure product specifications are met
• Perform technical root-cause investigations for aberrant results and deviations relating to analytical methods
• Collaborate closely with Interdepartmental MSAT and Manufacturing groups
• Perform additional duties as assigned

Preferred Qualifications

• Experience with relevant QC Microbiological assays is a plus
• Experience with contract laboratories and or CDMO is a plus
• Knowledge related to laboratory information management systems (LIMS) and electronic lab notebook record keeping (ELN) is a plus

Benefits

• The base salary range for this role is $75,000 - $98,000
• We offer an excellent benefits program including a selection of Medical, Dental and Vision plans, FSA, HSA, Company paid holidays, employee assistance program, commuter benefits, wellbeing resources, perks and more!