Description
Areas of Expertise * Business Process Improvement * Environmental Monitoring * Inventory Control & Management * Production Planning & Scheduling * Strategic Planning & Implementation * Process Design & Validation * GMP and ISO 13485 Compliance Recruited to establish Production Reva Medical San Diego, CA Established and directed formal operations functions supporting production of pre-clinical and clinical supplies collabored directly with Engineering, Quality and upper management to drive method transfer, training and document completion oversaw and led all production, logistics and quality control of coronary stent production. * Directed the implementation of formal documentation, training and processes to support clinical production compliant with the FDA QSR and ISO 13485 standards. * Expanded and developed production and quality teams to meet forecasts in support of design validation and clinical trials. * Developed and implemented the use of assessment and evaluate new hires in production and quality control. Quality Control and Operations systems and processes for in-vitro diagnostic oligonucleotides while ensuring compliance with cGMP and ISO 9001/13485 regulations. * Achieved certification for ISO 9001/ISO13485 by driving efforts and creating collaboration with partners including Quality Control upper management to establish procedures conduct training and facilitate efficient method transfer. * Significantly contributed company's bottom line by improving production processes for highly modified and complex oligonucleotides established Facilities Department which managed equipment and calibrations created Logistics Department which oversaw purchase orders inventory shipping and receiving. * Implemented metrics to measure performance and identify areas of improvement. Recruited to direct the high-throughput oligonucleotide bead pool and Veracode in-vitro diagnostic manufacturing groups to support 24/7 operations ensured compliance through proper training and lead cross-functional project to identify and implement replacement solvent due to acetonitrile shortage.
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