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Analyst I/II, Quality Control

GeneFab is seeking a contract Quality Control Analyst I/II 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 the execution of 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) 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  
  • 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 environment  
  • 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  
  • Proficient in MS Word, Excel, Project, and PowerPoint  
  • 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 


$35 - $45 an hour

About GeneFab 

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. 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. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.


We are committed to an inclusive and diverse GeneFab. 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. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.

Average salary estimate

$83200 / YEARLY (est.)
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$72800K
$93600K

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What You Should Know About Analyst I/II, Quality Control, GeneFab

Join the talented team at GeneFab as a Quality Control Analyst I/II in Alameda, CA! In this exciting role, you'll be instrumental in maintaining the quality assurance of our cutting-edge cell manufacturing processes. Your day-to-day will involve performing critical environmental monitoring, managing inventory, and analyzing trends. You’ll dive into reviewing GMP documentation linked to SOPs, testing methods, and protocols to ensure everything meets our high standards. With meticulous attention to detail, you will execute laboratory procedures and conduct QC tests on raw materials and final product samples. You’ll get to collaborate closely with talented folks in our MSAT and Manufacturing groups, providing the support needed for method optimization, troubleshooting, and qualification. This is not just a job; it's an opportunity to make a significant impact in the field of cell and gene therapy and contribute to innovative treatments. So if you're ready to take the next step in your career and be part of a passionate and diverse team, we want to hear from you!

Frequently Asked Questions (FAQs) for Analyst I/II, Quality Control Role at GeneFab
What are the responsibilities of a Quality Control Analyst I/II at GeneFab?

As a Quality Control Analyst I/II at GeneFab, you'll be responsible for executing and documenting lab procedures with great attention to detail, performing QC testing on various samples, and ensuring compliance with GMP requirements. You will also assess data for product specifications, assist in data review, and support root-cause investigations related to analytical methods.

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What qualifications do I need for the Quality Control Analyst I/II position at GeneFab?

To qualify for the Quality Control Analyst I/II position at GeneFab, candidates should hold a B.S. degree in biology or a related field. For Analyst I, 0-3 years of experience in fields like cell therapy, immunology, or cancer biology is required, while Analyst II candidates need more than three years of relevant experience. Familiarity with technologies such as flow cytometry and PCR methods is highly desirable.

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What kind of work environment can I expect as a Quality Control Analyst I/II at GeneFab?

As a Quality Control Analyst I/II at GeneFab, you'll work in a fast-paced environment that requires adaptability and self-motivation. The role may involve extended hours, including evenings and weekends, so being comfortable with changing priorities is essential. You'll collaborate with a diverse team committed to quality and innovation.

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What technologies should I be familiar with for the Quality Control Analyst I/II role at GeneFab?

Candidates for the Quality Control Analyst I/II role at GeneFab should have experience with multicolor flow cytometry, NGS, qPCR, and dPCR methods. Familiarity with microbiological assays and laboratory information management systems (LIMS) is considered a plus, enriching your contribution to the quality control processes.

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What is the salary range for the Quality Control Analyst I/II position at GeneFab?

The salary range for the Quality Control Analyst I/II position at GeneFab is between $35 - $45 an hour, depending on your experience and qualifications, which reflects our competitive compensation for professionals in the industry.

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Common Interview Questions for Analyst I/II, Quality Control
Can you explain your experience with GMP documentation as a Quality Control Analyst?

In answering this question, highlight your familiarity with reviewing and adhering to GMP documentation. Discuss specific examples of how you ensured compliance with SOPs and testing protocols and how this experience has prepared you for the responsibilities at GeneFab.

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How do you ensure accuracy in your quality control testing?

Discuss your methodology for ensuring accuracy, including maintaining meticulous records, following established SOPs, and conducting peer reviews. Quoting specific technologies or techniques you've used will add credibility to your response.

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Describe a time when you identified an issue in the lab and how you addressed it.

Provide a detailed example, focusing on the problem-solving process. Explain the steps you took to identify the issue, the data you reviewed, the collaboration involved, and the outcome. This demonstrates your critical thinking and teamwork skills.

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What is your experience with analytical methods relevant to the Quality Control position?

Be sure to list relevant analytical methods you've used, such as flow cytometry or qPCR. Explain how your experience correlates with the role at GeneFab and express your eagerness to apply this knowledge in a practical setting.

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How do you handle tight deadlines in a fast-paced environment?

Illustrate your method of prioritizing tasks and managing time effectively. Mention any tools or techniques you use to keep organized under pressure, and provide a specific example of how you successfully met a deadline in your previous work.

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Can you discuss your experience with root-cause investigations?

Talk about your approach to conducting root-cause analyses, including how you gather data and collaborate with team members. Provide insights into a specific investigation you've been involved in to illustrate your point.

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What role do you see technology playing in quality control processes?

Discuss the significance of technology in improving quality control, mentioning specific tools or systems like LIMS. Show your understanding of how technology can enhance efficiency, accuracy, and data management in a laboratory setting.

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How do you ensure proper record-keeping in the lab?

Emphasize the importance of accurate record-keeping in quality control. Explain the processes you follow to maintain records, including the use of electronic lab notebooks, and share any best practices you've mastered.

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Have you worked with interdepartmental teams, and how do you approach collaboration?

Share your experiences collaborating with other departments and the communication strategies you employed. Highlight how teamwork enhances quality outcomes and your ability to adapt your style to various team dynamics.

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What motivates you to work in quality control in the biotech industry?

Reflect on your passion for ensuring product quality and your interest in cutting-edge biotech innovations. Discuss any personal stories or experiences that fuel your commitment to quality and precision in the field.

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GeneFab is a contract development, manufacturing, and synthetic biology biofoundry focused on cell and gene therapies.

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Contract, on-site
DATE POSTED
December 17, 2024

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