YAZMIN CORREA ORTIZ

• Trained new employees and coworkers in Compression.
• Perform cleaning room, equipment and general area as per respective SOP(s).
• Clean up and Set up Compression Fette Model 2200i and Granulation, blending and packaging area.
• Dissemble and Assembly Fette Model 2200i.
• Adjust values to obtain standard operation procedures (weight, hardness and Friability Test).
• Review monitoring data for proper recording limits.
• Monitor and maintain recording devices coinciding with process records.
• Provide procedure to maintain proper control accountability during processing.
• Use equipment as Granulator, Moisture analyzers equipment, Fluid Bed Dryer and Comil to manufacture products with quality and integrity following Procedures (SOP) and GMP procedures.
• Organized work to meet demanding production goals with 100% success rate.

• Perform cleaning room, equipment and general area as per respective SOP(s).
• Clean up and Set up Compression Korsch Model XL 400.
• Dissemble and Assembly Korsch Model XL 400.
• Adjust values to obtain standard operation procedures (weight, thickness, hardness and Friability Test).
• Review monitoring data for proper recording limits.
• Monitor and maintain recording devices coinciding with process records.
• Provide procedure to maintain proper control accountability during processing of controlled substance and ensure remain in compliance with DEA regulations.
• Participate in Validation of new products.
• Inspected products and machines to maintain quality and efficiency.

Compression

• Trained new employees and coworkers in manufacturing areas.
• Help supervisor make decisions to complete day's production. Lead production room. Generate work orders and close them.
• Clean up and Set up Compression Fette. Dissemble and Assembly Fette 3090 and 3090i . Adjust values to obtain standard operation procedures (weight ,thickness, hardness and friability test). Manufacturing Execution Systems Electronic Batch Record (MES) through Human Interface terminals (HMI) and Agile Manufacturing Production System (AMPS). Generate Work Orders.
• Granulation Area
  Applies safety policies and GMP knowledge in daily operations involving self and other team members. Perform cleaning room, equipment and general area as per respective SOP(s). Set Up, clean and operate Fluid Bed, Diosna, Kason, Frewiitt and Fitmill equipment and rooms following weekly manufacturing schedule and related SOP(s). Transfer materials between work centers as needed to meet daily schedule. Monitors operating parameters and physical attributes of product process during each respective manufacturing step. Address process deviation immediately and participle in troubleshooting with other team members. Performs routine preventive maintenance, minor repairs and basic troubleshooting on manufacturing equipment and instruments. Knowledgeable also in execution of Mixing manufacturing process for dry and wet granulations of solid dosage product. Execution of testing from formulation granulation moisture content through titration (karl Fischer) and NIR (Near Infrared Method). Knowledgeable in manufacturing operations execution of data entries in various processes from formulation through dosage in Manufacturing batch records and paperless Manufacturing Execution Systems Electronic Batch Record (MES) through Human Interface terminals (HMI).
  
• Film Coating Area
  Clean up and set up Accela Cota Film Coating Equipment, Monitors and Adjusts process parameter during manufacturing stage, Disassembles and reassembles equipment used, Processes formula ingredients to produce solution for Film Coating Tablets.
  
• Reconciliation Area
  Clean up compression rooms. Transfer Raw materials from reconciliation to processing area.
  In-Process Lab
  Take disintegration of tablets, friability and Weight variation.
  
• Document Review
  Responsible to review all documentation per stage of process and make sure that all signature and dates are completed before sending to QA.

• Package Bottles, Blisters and Vials, Assistant Retention of Samples Area.
• Oversaw incoming packaging products and monitored quality of outgoing products to comply with specifications.
• Completed processing activities to conform with laws, safety standards and product hygiene standards.
• Labeled, recorded and inspected packaging to prepare for shipment or storage.

• Performed Packaging Operations, Responsible for Cleaning Equipment and Setting up Packaging Lines and Supplying Components During Packaging Operations, Performed Quality In-Process Checks, Reconciles Printed and Non-Printed Packaging Components; Prepares Finished Production Handling Units Using SAP System, Performs Direct Labor Functions as Relief Operator.