GeneFab
Quality Control Analyst I/II
Alameda, CA · Mid · Contract
Sponsorship not specified$35k-$45kDetected 112 days ago
ExcelGMPqPCRFlow CytometryNGSCell CultureMicrosoft Office
About the role
- GeneFab is seeking a Quality Control Analyst I/II to help ensure consistent quality of our cell manufacturing process.
- We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
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
- Perform 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 the execution of method optimization, characterization, troubleshooting, transfer, and qualification
- Perform additional duties as assigned
- GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production.
- We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team.
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 with an emphasis on multicolor flow cytometry, MSD, Immunospot, cell culture (e.g., aseptic techniques, cell line expansion), multiplexed immunoassay, NGS, qPCR, and dPCR methods
- Experience with assay development, method qualification, and routine testing in GLP and/or GMP environment
- Proficient in MS Word, Excel, Project, and PowerPoint
- 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
Nice to have
- 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
- Experience with gene and cell therapies or the pharmaceutical industry is a plus
Compensation
- Salary and Benefits:
Benefits
- The base salary range for this role is $35-45; starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity
- 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!
- GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines.
Company info
- We are committed to an inclusive and diverse GeneFab.
Equal opportunity
- equal opportunity employer.
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This listing is sourced directly from GeneFab's careers page and normalized into a canonical job model.