Clinical Manufacturing Quality Assurance Analyst 1

Stanford University is seeking a Clinical Manufacturing Quality Assurance Analyst 1 (Quality Assurance Associate to support the implementation and maintenance of quality assurance processes and procedures for the Laboratory for Cell and Gene Medicine (LCGM). The ideal candidate possesses strong collaborative skills who is flexible to changing priorities in a fast-paced and cross-functional environment. 

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 early phase clinical trials.

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!

Learn more about our team here: https://med.stanford.edu/lcgm.html

Duties include:

• Perform the receipt, inspection, and release of incoming material as required per LCGM procedures
• Assist with qualification activities for suppliers of raw materials, service providers, and contract testing laboratories.
• Support quality assurance operations required to support clinical manufacturing, including maintaining and compiling documents to support cGMP and clinical manufacturing.
• Perform routine quality activities, identify and initiate deviations/change controls, and escalate issues to senior QA staff.
• Assist with data collection for metrics and analysis.
• Assist in creating training material.

* - Other duties may also be assigned

Responsibilities

Core Duties:

• Perform the receipt, inspection, and release of incoming material as required per LCGM procedures.
• Assist with qualification activities for suppliers of raw materials, service providers, and contract testing laboratories.
• Support quality assurance operations required to support clinical manufacturing, including maintaining and compiling documents to support cGMP and clinical manufacturing.
• Perform routine quality activities, identify and initiate deviations/change controls, and escalate issues to senior QA staff.
• Assist with data collection for metrics and analysis.
• Assist in creating training material.

Minimum Education and Experience

Associate’s degree with 0-1 year of relevant experience or an equivalent combination of education and relevant experience.

Knowledge, Skills, and Abilities:

• Basic knowledge of GMP preferred.
• Excellent interpersonal skills and customer service focus.
• Knowledge/experience if office software and database applications.
• Ability to communicate effectively both orally and in writing.