Stanford University School of Medicine · 2 days ago
Quality Assurance Associate
Stanford, CA
Full-time
Onsite
Entry Level
$36.73/hr - $42.50/hr
1+ years expStanford University is seeking a Clinical Manufacturing Quality Assurance Analyst 1 to support the implementation and maintenance of quality assurance processes for the Laboratory for Cell and Gene Medicine. The role involves assisting with documentation, regulatory submissions, and ensuring compliance with cGMP standards.
EducationHigher EducationMedical
Responsibilities
Assist with developing, drafting, maintaining, and compiling process related documents to support cGMP (current Good Manufacturing Practice) clinical manufacturing
Support with generating procedures by following set guidelines and provide suggestions for issues found in documentation processes
Assist with Investigational New Drug (IND) submissions to the Food and Drug Administration by compiling and providing supporting documentation and answering questions for regulatory affairs during the application process
Identify, classify, and report deviations from the process and/or protocols to provide recommendations and process improvements to Product Development/ Manufacturing (PD/MFG) and Quality Control, to ensure compliance with all applicable regulations, and to assist in the resolution of issues
Escalate critical issues within assigned area to senior management team based on severity of the issue
In support of clinical trials, review batch records and product dispositions to ensure process is performed per procedure guidelines and address any deviations
Assist with the development of standardizing processes for review and maintaining Standard Operating Procedure (SOPs), batch records, raw materials specifications, certificate of analysis, training records etc
Execute quality assurance operations required to assess, evaluate, and review processes against cGMPs
Perform real-time observation of activities and issue identification/resolution 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
Participate in regulatory, quality and compliance meetings to represent Quality Assurance
Responsible for compiling, organizing and storing all documentation related to FDA and cGMP regulations including developing and maintaining a system for storing documents
Provide support to 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
Qualification
Required
Bachelor's degree and one year relevant experience or an equivalent combination of education and relevant experience
Knowledge of GMP/ ISO compliance, and quality systems
Applicable or related experience in a quality-related work in a cell therapy/biotech manufacturing setting
Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
Experience with office software and database applications
Excellent inter-personal skills and customer service focus
Ability to communicate effectively both orally and in writing
Preferred
Must be able to work effectively in a fast-paced environment with cross-functional groups involved in multiple projects and timelines
Must be flexible in supporting changing priorities while maintaining a collaborative approach
Must be able to work independently with some supervision
Bachelor's degree in Biology, Chemistry, or Life Science preferred
Company
Stanford University School of Medicine
Stanford University School of Medicine is the medical school of Stanford University. It is a sub-organization of Stanford University.
5001-10000 employees
H1B Sponsorship
Stanford University School of Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (551)
2024 (499)
2023 (472)
2022 (390)
2021 (336)
2020 (260)
Funding
Current Stage
Late StageTotal Funding
$10MKey Investors
American Medical Association
2023-06-21Grant
2017-07-19Grant· $10M
Leadership Team
Darius M. Moshfeghi
Chief of Retina Division: Vitreoretinal Surgery and Medical Diseases
Quinton R. Markett
Research Professional, Utz Lab, Department of Medicine, Division of Immunology & Rheumatology
Recent News
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