Overview
QC Analyst , QC Analytical Jobs in Alameda, California, USA at GeneFab
Position: QC Analyst 1, QC Analytical
Gene Fab is seeking a contract Quality Control Analyst I to help ensure consistent quality of our cell manufacturing process. You will perform environmental monitoring, inventory management, and trending. As part of this role, you will also review current GMP documentation related to SOPs, testing methods, and protocols.
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
Assist in reviewing data
Support technical root-cause investigations for aberrant results and deviations relating to analytical methods
Responsible for raw materials inspection, sampling, and testing in support of clinical and commercial products in compliance with GMP requirements
Collaborate closely with interdepartmental MSAT and manufacturing groups to support, execute, and/or provide oversight in method optimization, characterization, troubleshooting, transfer, and qualification
Perform additional duties as assigned
Qualifications
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)
Experience with relevant technologies, emphasizing multicolor flow cytometry, MSD, Immunospot, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, NGS, qPCR, and dPCR methods
Able to support overtime work such as evenings and weekends
Experience with relevant QC microbiological assays is a plus
Experience with assay development, method qualification, and routine testing in GLP and/or GMP environments
Experience with contract laboratories and/or CDMO is a plus
Knowledge of laboratory information management systems (LIMS) and electronic lab notebook (ELN) record keeping is a plus
Proficient in MS Word, Excel, Project, and Power Point
Experience with gene and cell therapies or the pharmaceutical industry is a plus
Availability to work extended hours to meet deadlines when necessary
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description
Able to lift up to 40 pounds
Salary: $30 – $36 an hour
About Gene Fab
Gene Fab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. Founded in 2023, our vision is to combine industry-leading expertise in synthetic biology with advanced cGMP capabilities to accelerate the development and commercialization of genetic medicines. We offer an extensive technology platform and know-how spanning early-stage product design, technical development, and cGMP compliant production. Our platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.
We are committed to fostering an inclusive and diverse environment  believe that different perspectives lead to better ideas, enabling us to better serve the needs of our diverse team. We welcome applicants from all backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
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Title: QC Analyst , QC Analytical
Company: GeneFab
Location: Alameda, California, USA
Category: Healthcare (Data Scientist), Quality Assurance – QA/QC (Data Analyst)
