Rosangelí Lebrón Marcos

• Performs routine laboratory and EM activities..

• Performs tests such as (but not limited to) bioburden, BET, sterility, Growth Promotion, incoming media/reagent QC, BI testing.

• Operates laboratory equipment used to provide sterile and depyrogenated materials.

• Read EM and testing plates and assess against alert and action levels as appropriate.

• Performs microbial isolation techniques, Gram stains and supports microbial identification process.

• Performs environmental monitoring activities in support of manufacturing.

• Collects utility samples for analysis.

• Maintain qualification status on aseptic gowning, sterility testing, BET, etc.

• Demonstrates aseptic technique when performing a Microbiological Test or EM.

• Perform testing/monitoring activities associated with protocols or special projects as required.

• Executes scheduled testing and monitoring activities within the QC lab and manufacturing facility.

• Good understanding of how Environmental Monitoring programs work to keep Aseptic Processing Areas qualified for manufacturing processes
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• Execute procedures following Standard Operation Procedures
• Perform and monitor critical processes
• Support quality products such as Enbrel, Repatha and clinical trial studies for product campaign BEMA™
• Perform bioreactor procedures CIP, PT, SIP, assembly, disassembly
• Perform filter integrity testing as part of the pharmaceutical manufacturing processes
• Verify and document daily activities following Good Documentation Practices
• Experienced with analytical sample equipment such as BGA, Cedex, NOVA, YSI
• Calibrate sample testing machines to maintain required productivity levels and adherence to quality standards.
• Worked with MO's

• Organize supplies, maintained equipment and prepared laboratory environments for student learning
• Set up, maintained and verified sterility of laboratory equipment and tools
• Wash equipment, glassware, beakers, flasks used by students
• Used of equipment (Autoclave) and preparation of Agar Plates
• Inspection of laboratory equipment to maintain good working condition for optimal results