Quality Assurance Associate

🔍School of Medicine, Stanford, California, United States. Stanford University is seeking a Clinical Manufacturing Quality Assurance Analyst 1 to support implementation and quality assurance processes for the Laboratory for Cell and Gene Medicine (LCGM).

• Assist with developing, drafting, maintaining, and compiling process related documents to support cGMP (current Good Manufacturing Practice) clinical manufacturing.
• Assist 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 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.
• 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.

• 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.
• 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 quality 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.

• Frequent desk-based computer tasks, lift, carry, push/pull objects up to ten pounds. Occasionally need to lift, carry, push and pull objects up to thirty pounds.
• Employee must perform tasks that require personal protective equipment, such as safety glasses, shoes, protective clothing and gloves, and possibly a respirator.
• May require working in close proximity to blood borne pathogens, hazardous materials, infectious diseases, high voltage electricity, radiation, electromagnetic fields, lasers, noise above 80 dB TWA, allergens, biohazards, chemicals, confined spaces, working at heights.
• May require extended or unusual work hours based on research requirements and business needs.

All members of the Department are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion and justice are central. The Department publicly commits to promoting anti‑racism and equity through its policies, programs and practices at all levels.

Pay range: $36.73–$42.50 hourly (California Bay Area).

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