Grade: F

FTE: 100%

Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Assistant (CMQCA1) to perform various routine quality control testing for Microbiological (endotoxin, mycoplasma, sterility gram stain) testing and sample preparation and biologics (flow cytometry, qPCR, etc.) assays supporting clinical product manufacturing consistent with principles of current Good Manufacturing Practice (cGMP) and aligned with the phase of the clinical investigation for treating patients with incurable diseases.

Duties include:

• Perform Microbiology Testing (LAL), QC Assays (Flow Cytometry, PCR, Sterility, Endotoxin, etc.) and prepare samples for sterility testing per test procedures. Adhere to requirements of the method and good documentation practices. Document and maintain environmental monitoring data and generate monitoring reports
• Document performance of analytical methods in order to be consistent with current GMP and documentation practices.
• Support document revision/creation in collaboration with PI and QC project lead. Adhere to cGMP compliance requirements to maintain inspection-ready state. Collect, interpret and perform basic analyses and reporting of data from test results. Recommend modifications for optimization or clarification of test procedures, protocols, and assays in collaboration with quality control, quality systems management, Principal Investigator (PI) and project team.
• Manage, maintain, monitor, and order QC raw materials and supplies
• Monitor and troubleshoot pertinent equipment; Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date. Coordinate equipment implementation for use and decommissioning activities.
• Participate in the investigation of out-of-specification and/or non-conforming test results.
• Prepare deviation reports per SOPs with input and oversight from supervisor. Implement prevention or corrective actions based on supervisor feedback.
• Participate in the development and maintenance of QC related SOPs, test procedures, training records, and other QC-related documentation.
• Perform QC Support tasks – e.g. equipment maintenance, tracking of reagent and sample inventory, organization of the lab, checking to ensure removal of expired media performed, etc.
• Coordinate the timely shipment of samples to contract laboratory for testing (e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample).

• - Other duties may also be assigned

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $66,000 to $76,000.

As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy