• Controls operating supplies and coordinates operations required to support the controlled environment.• Manages manufacture of WBC, RBC, and PLT subassemblies, product fills, and finished product packaging operations; supervises washing, wrapping, and autoclaving of operating supplies.• Troubleshoots process problems as they occur and notifies appropriate personnel.• Communicates with QC regarding weekly schedule and efficient turn-around of samples and test results.• Performs final review of batch records/BOMs for completion and accuracy; tracks CMA Quality objectives and takes appropriate actions for improvement.• Ensures proper statusing of subassemblies and vials when released by QA Manager.• Maintains subassembly and finished product inventories; completes month end close.• Initiates appropriate documentation for any observed/identified nonconformance with process or product.• Organizes and schedules materials and manpower to accomplish production schedule efficiently.• Reviews autoclave documentation for thoroughness and accuracy.• Ensures timely calibration of equipment; ensures its proper use and maintenance.• Reviews and addresses Temperature/Humidity deviations and water system issues in operational areas.• Promotes continuous improvement of processes, workplace safety, and environmental practices.• Maintains, updates, and creates documents related to Control Manufacturing.• Helps employees to address and resolve concerns and conflicts as they arise.• Trains new employees in CDS Quality System, Manufacturing Work Instructions, and Safety; trains seasoned employees in new processes and document revisions.• Evaluates employee performance on a yearly basis.• Serves as a team member during pilot pool manufacture, document development, and transfer of product to manufacturing.• Ensures Manufacturing Work Instructions, Good Documentation Practices, and GMP’s are followed.• Ensures compliance of product and process to Quality Procedures.

• Controls operating supplies and coordinates operations required to support the controlled environment.• Comply with FDA cGMP safety requirements, manufacturing documentations, and SOP• Performs ATC (Authorization to Commence) prior to all manufacturing operations.• Performs manufacture of WBC, RBC, and PLT subassemblies, including technique dependent aspiration of packed cells, product fills, as needed to support product schedule.• Coordinates sampling and cleaning of filled product tubes prior to labeling.• Coordinates start-up, shutdown and cleaning of controlled environment.• Coordinates washing, wrapping, and autoclaving of operating supplies.• Verifies Autoclave Load Configurations and packaged item documentation; operates autoclave.• Reviews autoclave documentation for thoroughness and accuracy.• Reviews Temperature, Humidity and Water system readings daily.• Monitors inventory of purchased operating supplies, orders items as needed.• Troubleshoots process problems as they occur; interface with other department personnel as needed.• Ensure compliance to Manufacturing Work Instructions, Good Documentation Practices, and GMP’s are followed.• Reviews batch records and Bill of Materials for completion and accuracy before submitting for final Manufacturing Review.• Maintains subassembly and finished product inventories.• Ensure availability of materials and manpower for operations required to support the controlled environment.• Partners with QA Coordinator to maintain equipment calibration, verification and/or maintenance as required.• Trains employees in new processes, safety and document revisions.• Serves as lead manufacturing team member during pilot pool manufacture, document development and transfer of product to manufacturing.

Under minimal supervision perform and coordinate various technical and complex tasks to manufacture Hematology controls and calibrators. ●Perform manufacturing of WBC, RBC, and PLT subassemblies, including techniques dependent on aspiration of packed cells.●Performs manufacturing of Primary Hematology Pools and Final Hematology Pools.●Coordinate final product fills●Complete and review batch records/Bill of Materials before submitting for final QA Manufacturing Review.●Trains and coach new employees on aseptic technique, safety procedures, and processes.●Trains employees in new processes, safety updates, and document revision.

Responsibilities: • Comply with safety requirements upheld in manufacturing documentations, and cGMP SOPs·Cell Banking·Mammalian Cell Culture Optimization and Proliferation·Cell Line maintenance: aseptically feed, passage/split, and feed cells.·Prepare Buffer and Media solutions·Data Analysis·Assist with writing SOPs, batch records, and CPs• Perform conductivity and pH measurements• Clean, assemble, and autoclave equipment for production

Research Title: The effect of ethanol exposure on nervous system development in zebrafish during embryonic development.Awards: Annual Biomedical Research Conference for Minority Students (ABRCMS) Presentation Award (Nov 2012), ABRCMS Travel Award Recipient.Responsibilities: Observation and documentation of developmental abnormalities in zebrafish embryos following exposure to different ethanol concentrations.Techniques:• Wet Chemistry• in situ hybridization• DNA mini preps• Gel electrophoresis• Digital/video microscopy