Experience

Kedrion Biopharma

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Warehouse Supervisor

  • Jan 2020 - Present

  -Establish a quality-driven warehouse for the company. -Liaise with Kedrion Biopharma to partner with Lineage Logistics. -Develop standard operating policies for a new warehouse through quality assurance, quality control, engineering and warehouse procedures. -Mentored and trained new hires on company and system protocols. -Performs scheduling, coordinating and oversight of the quality stream activities in the warehouse-Monitor the Quality Warehouse team everyday work supporting decisions with quality and compliance issues and effective communication with Operations, Management, and other departments-Coordinates and troubleshoots QC activities in relation to incoming materials and associated sampling-Coordinate routine data collection and prepare trend reports for evaluation. Show less

• Quality Manufacturing Specialist

  • Apr 2018 - Jan 2020

  - Performed sampling, testing and inspection of raw material and components. - Documented the results in compliance with cGMP and company procedures.- Maintained quarantine/release/reject system for raw materials, labeling materials, and finished drug products.- Sustained safe, clean and organized work areas.- Reviewed and issued completed batch records and associated forms to production.- Assessed Corrective and Preventative Actions (CAPA); including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.- Operated with all functions to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations. - Performed and assisted with plasma, Red blood cell unit, intermediates, labeling and packaging inspection. - Performed daily routine inspections and documentation of operations floor activities, systems, utilities, and facilities as per cGMP requirements. Show less

• Quality Control Inspector

  • Feb 2015 - Apr 2018

  - Completed periodic line clearance for manufacturing.- Verified raw materials against quality standards and adherence to specification.- Created material specification procedures to align with quality standards.- Documented and reported deficiencies to upper level management.

• Clarification Operator

  • Jan 2010 - Feb 2015

  - Performed accurate in-process plasma inspections.- Pooled the plasma to start the fractionation process. - Ensured highest quality of the final product in a seamless and