Stanford University is seeking a Quality Assurance Associate who contributes to ensuring compliance of the Laboratory for Cell & Gene Medicine with pertinent Federal and State regulations governing the manufacturing of cell and gene therapy products for Phase I/II clinical trials conducted under Investigational New Drug (IND) applications. The QA Associate will contribute to the production, distribution and review of documentation related to manufacturing and release testing of products. Associate ensures that facilities and manufacturing operations are conducted according to cGMP; provides training and certification of manufacturing and QC staff; controls distribution, tracking and archiving of clinical materials and provides validation support for all equipment, processes, and approves all outcomes, which are essential to the production of biotechnical products. The QA Associate will act as a liaison for the LCGM and interact with clinical and research investigators, regulatory affair staff and vendors. This position reports directly to the LCGM Associate Director of Quality Systems.
Work with Quality Team, Executive Team, and all relevant stakeholders to improve quality checks and release criteria; interact with other staff to ensure Quality System policies and procedures are understood and implemented to meet the goals of the LCGM. Conduct batch record review and approval to ensure that agreed-upon timelines are met and approve responses to batch record review comments. Contribute to Standard Operating Procedures (SOPs); Master Manufacturing Records, Production Batch Records and all relevant facility documentation; review and approve site procedures related to manufacturing, production activities Contribute to CA state license to manufacture biologics. Contribute to developing, implementing, communicating and maintaining a quality plan to bring facilitys Quality Systems and Policies into compliance with International Organization for Standardization (ISO)/cGMP Quality system requirements. Assist with Quality Management System (QMS) for Document Control software. Contribute to internal and external audits to ensure we are compliant to QMS and ISO standards. Contribute to implementation and training efforts to ensure site is compliance with relevant state & FDA regulations Contribute with implementing Quality Policies, Validation Master Plans, Site Master Plans, etc. Contribute to release of raw materials and finished products to assure supply chain of product.
* - Other duties may also be assigned
EDUCATION & EXPERIENCE (REQUIRED):
Bachelors degree and three years of related experience or a combination of relevant education and experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Excellent communication skills and superb attention to detail. Experience with MS Office products and database applications required. Excellent inter-personal skills and customer service focus is required. Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB. Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. Strong writing skills.
CERTIFICATIONS & LICENSES:
Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds. Occasionally sit, use a telephone or write by hand. Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains d...edicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu.
Stanford University is an equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.