Quality Assurance Associate (Gmp Certificate Program)

Grade: F

FTE: 100%

Stanford University is seeking a Quality Assurance Associate (CMQAA1) to support the implementation and maintenance of quality assurance processes and procedures consistent with the principles of current Good Manufacturing Practices (GMP) for the Laboratory for Cell and Gene Medicine (LCGM).

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:

• Responsible for compiling, organizing, and storing all documentation related to cGMP regulations including developing and maintaining a system for storing documents.
• Provide support for cGMP compliance audits of vendors, contract manufacturers, contract laboratories and quality systems by preparing and reviewing all documents, tracking timelines, and handling back-office operations during site visits.
• Perform quality assurance activities including but not limited to deviation initiation/review, change control initiation, materials management activities, compiling data , organization and verification of Quality System documents, material kitting, etc.
• Other duties may also be assigned
• Perform real-time observation of activities including proper and timely documentation.
• Provide resolution of quality assurance issues/documentation in compliance with LCGM policies, cGMP, and Institutional Review Board (IRB) protocols. Report quality issues internally and to appropriate departments.
• Identify, classify, and report deviations associated with processes and/or protocols and provide issue resolutions and process improvements to Product Development/ Manufacturing (PD/MFG) and Quality Control.
• Generate and issue documents (e.g. batch records, labels, forms associated with clinical manufacturing)
• Assist with maintaining and compiling of process related documents to support cGMP (current Good Manufacturing Practice) clinical manufacturing. Support generating procedures by following set guidelines and provide suggestions for issues found in documentation processes.
• Assist with the development and maintenance of Standard Operating Procedure (SOPs), batch records, raw materials specifications, certificate of analysis, training records etc.

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 $71,000 to $84,000..