Quality Control Associate I (Gmp Certificate Program)

Grade: F

FTE: 100%

Stanford Laboratory for Cell and Gene Medicine (LCGM) is seeking a Quality Control Associate I (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.

LCGM is a GMP multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children’s Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients in Phase I/II clinical trials.

Innovations in Cell & Gene Therapy represent some of the most promising advancements in the field of biotechnology today. Behind these extraordinary innovations is a workforce that is expected to grow between 50 and 100 percent in the years to come. LCGM is looking to address this gap by creating a NEW Cell & Gene GMP Certificate Program.

Be an Employee-in-Training and Earn while you Learn as you start your bright biomedical career. The Cell & Gene GMP Certificate Program consists of GMP focused instruction, functional unit rotations, and one year of specialization. We aim to increase opportunity, access, equity, and inclusion as we develop a skilled cell and gene therapy manufacturing and quality workforce.

LCGM is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. We invite you to join our team!

This is a fixed term position of up to 18 months

Duties include:

• 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.
• Document performance of analytical methods in order to be consistent with current GMP and documentation practices.
• 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.
• 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
• Participate in the investigation of out-of-specification and/or non-conforming test results.
• 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.
• Prepare deviation reports per SOPs with input and oversight from supervisor. Implement prevention or corrective actions based on supervisor feedback.
• 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