Quality Control Associate III-I (620FB)

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Job description

Fate Therapeutics is seeking a highly motivated Quality Control (QC) Associate with molecular biology assay experience, including qPCR, ddPCR and DNA/RNA extraction, to support its expanding cellular therapy programs. This role will support manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GXP environment. Additionally, this role may provide limited technical support and troubleshooting for the support of IPC, lot release, and stability testing. The successful candidate will execute tasks associated with the sample management, shipping, and other lab support for QC functions, as well as have cross-functional interaction with personnel from other QC groups. This is a full-time position reporting to the Scientist or Manager, Quality Control and is located at our corporate headquarters in San Diego, CA.

Responsibilities

• Support the Molecular Biology group in quality control department.
• Work with the team to perform on bench molecular biology testing for in-process control (IPC), lot release, and stability testing of clinical drug product.
• Execute processes to support sample receipt and processing for release/stability samples for testing and retains.
• Ensure proper and timely completion of testing and tasks as assigned.
• Revise test methods or equipment SOPs, raw material specification, and/or sample plans as appropriate.
• Work with Materials Management, QA and other QC functions including Corporate QC to implement and support requirements around Raw Material sampling, testing and disposition.
• Participate in cross-functional training.
• Identify and facilitate continuous improvements in QC laboratory and systems.
• Maintain instrumentation and supporting documentation in a cGMP compliant manner.
• Assist in the implementation of new assay methodologies and the associated instrumentation.
• Identify and support initiation and completion of deviations, CAPAs, and laboratory investigations.
• Responsible for receipt and entry of contract testing lab samples.
• Perform any combination of sample management tasks, including labeling, preparing for shipping, inventorying, and disposing.
• Review and verify sample paperwork against samples to ensure accuracy and communicate discrepancies.
• Assist with stability studies as needed and directed, including removal of samples from stability and verification of information.

Qualifications

• B.S. degree in Biological Sciences or other related field, with a minimum of 2 year of biotechnology, clinical, or pharmaceutical QC laboratory experience.
• Prior experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.
• Hands on experimental skills qPCR and ddPCR assays is required; experience with BioRad CFX and QX are strongly preferred.
• Proficiency with aseptic techniques for working with cell culture, DNA/RNA, human blood, and blood products is desired.
• Prior experience (1+ years) in sample coordination highly desired.
• Strong scientific, analytical, problem solving, and communication skills as well as sound judgment.
• Ability to work effectively both independently and with others.
• Highly organized, detail oriented with excellent record keeping abilities, and computer proficiency.
• Ability to work in a fast-paced team environment, and prioritize activities from multiple projects with supervision from manager.

Working Conditions and Physical Requirements

• Will require working with cells and cell lines of human and/or animal origin.
• Occasional evening and weekend work will be required.
• 100% on-site work at corporate headquarters in San Diego, CA

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.