Luisa Rancapan

Swiftwater, PA · May 2025 – Present

• Carry out manufacturing activities for bulk vial products, including vial filling in an isolator using aseptic technique
• Take part in media fills (aseptic process simulations)
• Set up VHP decontamination of the isolator before production runs
• Monitor the filling line HMI and help resolve line issues
• Perform visual inspection of filled vials and water sampling; support environmental monitoring (EM)
• Reconcile batch records and keep documentation GDP-compliant
• Perform aseptic gowning and support cleanroom sanitization

Ridgefield, NJ · Jan 2024 – May 2025

• Filled bulk syringe products, covering all manufacturing activities on the line
• Prepared for production: batch records, component staging, and sterilization of cleanrooms and isolators using aseptic technique
• Assembled and disassembled filler machines using aseptic technique
• Monitored the HMI and identified and resolved syringe filling malfunctions
• Worked in an E-beam radiation environment under its safety and operating protocols
• Inspected finished syringes, logged defects in Code Nest Reports, and rejected syringes with gross defects
• Collected samples for the microbiology and chemistry labs and reconciled batch records
• Labeled and palletized finished syringes for transfer to the warehouse
• Took part in qualification/validation activities and assisted with deviation investigations and inspections

Allendale, NJ

• Prepared sanitizing agents and sanitized Grade A–D manufacturing rooms using aseptic technique and sterile wipe-folding methods
• Sanitized manufacturing equipment and transported material supplies using aseptic technique
• Trained new team members on SOPs
• Maintained batch records following Good Documentation Practices

Allendale, NJ

• Assisted in manufacturing collagen-based wound care products according to batch records
• Prepared and formulated solutions, processed them in freeze dryers, and shaped them into wound care products
• Operated, monitored and sanitized production equipment; monitored data loggers; assisted with calibration
• Recorded production data, kept detailed manufacturing logs, and reconciled batch records
• Visually inspected product and pulled rejects