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Job #03479

About our client Our client is the rapidly growing research division of a large, non-profit blood center. The organization has financial backing from their stable parent company in addition to being government-funded, and is focused on the long-term professional development of it's employees Position Location Director of Quality Assurance New York, NY Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversees the Quality Program of to ensure that all procedures and validations conform to FDA Guidelines, Accrediting Agency Requirements (FACT) and NY State Regulations 2) Reviews with the Medical Director pertinent quality standards to maintain a quality management system that assures monitoring of key process functions 3) Identifies measures of quality 4) Monitors quality routinely throughout the production process 5) Performing audits, and following up on observations including corrective or preventive actions 6) Oversees SOP development, training and implementation 7) Identifying trends or recurring problems, managing investigations and corrective actions 8) Reviews and approves validation protocols and reports 9) Participates in the BLA planning, preparation and submission process Requirements 1) Minimum of 10 years experience in Quality Assurance 2) Bachelor's degree (Master's desirable) 3) Experience with the preparation and submission of Biological Licenses Applications (BLAs) 4) Experience with cell manufacturing preferred 5) Experience with six sigma or equivalent beneficial 6) OJT courses from ASQC desirable