DANA SHAMITZ

• Coordinate and execute Material Disposition for various product types adhering to Quality Standards and within service level agreements. This includes coordination of all inputs to the disposition process such as Batch and Analytical record review
• Issue documentation (batch records, logbooks, lab notebooks)
• Perform Log sheet and documentation reviews
• Primary contact for event reporting including escalation of critical issues to Senior Management
• Managing the implementation, and execution of deviations (events), CAPA's, Change Controls, facility events, product and environmental investigations and SOP development
• Facilitates closure of Class I, II & III Event Reports
• Administer Quality training to include cGMP, GDP, Audit Preparation and Investigational Writing and Root Cause Analysis.
• Quality lead for External and internal audits. Support Regulatory and Compliance audits.
• Organize and lead Material Review Board (MRB)
• Support Quality activities at Fulfillment and Lab site as Lab Coordinator (Woburn, MA)
• Perform facility walkthroughs
• Supervise and assignment of work to Quality Associate and Quality Contractors
• Analyze and report key quality metrics for deviations, CAPAs, Change Controls, employee training and environmental controls in monthly reports and Quarterly Management Reviews
• Facilitate the lifecycle of controlled documents (document creation revision, and obsoletion)
• Review and approval of Master documents impacting operations including SOPs, Master Batch Records, Test Methods and Work Instructions
• Review and approval of test protocols and reports for various studies, stability and validation / qualification activities
• Exercise professional written and verbal communications skills in supporting customer and team member needs
• Contributor on cross functional project teams
• Provide Quality input and oversight to operational projects
• Support continuous improvement in culture within Quality through internal and external training
• Keeping up with changes in accounting standards and technologies through continuous learning
• Drive improvements to Quality systems in alignment with Quality continuous improvement initiatives including potential automation of key systems
• Super User for OpenBiome's eQMS system (MasterControl, Centraxx, BOX, DocuSign)

• Perform batch record review
• Perform Log sheet review
• Initiate deviation (event) investigations
• Facilitating closure of Class I Event Reports
• Initiate Change Controls
• Tracking of deviations, CAPA's, metrology discrepancies, facility events, product and environmental investigation and SOP development
• Perform facility walkthroughs
• Perform documentation issuing (batch records, logbooks, lab notebooks)
• Facilitate the lifecycle of controlled documents (document creation revision, and obsoletion)
• Support Regulatory and Compliance audits
• Provide Quality oversight for the shipment of Enforcement Discretion and Clinical Research finished product. Signatory on material shipment documentation
• Provide Quality input and oversight to operational projects
• Quality liaison for OpenBiome and Fulfillment office proprietor
• Maintain document control
• Coordinate archiving documents to offsite storage
• Assist with document recalls from offsite storage
• Exercise professional written and verbal communications skills in supporting customer and team member needs
• Contributor on cross functional project teams
• Support and maintain the effectiveness of the Quality System
• Keeping up with changes in quality standards and technologies through continuous learning

• Media preparation and batch record completion
• Entry of in-process data into trending databases
• Evaluate opportunities for production process improvement and efficiency
• Managed daily tasks consistently and sought out opportunities to go beyond requirements and support business targets
• Supported daily operation by completing assignments with strong focus on quality and performance
• Reviewed activities regularly to identify opportunities for improvement

· Media preparation and batch record completion
· Entry of in-process data into trending databases
· Evaluate opportunities for production process improvement and efficiency
· Managed daily tasks consistently and sought out opportunities to go beyond requirements and support business targets
· Supported daily operation by completing assignments with strong focus on quality and performance
· Reviewed activities regularly to identify opportunities for improvement