Experience

Old Wisconsin Sausage

• QA

  • Daily Quality Check throughout production areas. • Monthly Internal Audit. • Performing pre-op. throughout production areas. • Understood and Adhere to cGMP Compliance. • Monitor temperature of product storage and microbiology incubator. • Calibrate pH meter, Scale, and thermometer. • Monitor and maintain product shelf life. • Write and revise Standard Operational Procedure (SOP). • Successfully conducting Aerobic Plate Count (APC) and Adenosine triphosphate (ATP) program for Sanitation. • Sampling environmental monitoring by using aseptic technique. • Performing analytical testing and microbiology plating. • Read and interpret micro-plate. • Collect and foss finished product for fat, moisture, and protein. • Data entry. • Organize and order lab suppliers. • Prepare Salt solution for stuffing department. • Organized and file HACCP. • Updating training log as needed. • Conducting schedule for all QA-tech to follow. • Help to organized meeting or event.



Ethicon, Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• QC Microbiologist

  • Aug 2015 - Jul 2016

• QC Microbiologist

  • Aug 2015 - Jul 2016

  Wrote protocols for validation study, performed product risk assessment on water utilization system, conducted plan wide microbiological contamination training for production, assisted manufacture operation such as sanitation and sterilization process, performed bioburden and endotoxin testing as needed, helped QA team with deviation investigation and product released, assisted projects in environmental monitoring, and attended scientific meeting in associate field.



Old Wisconsin

• QA- Technician

  • Mar 2011 - Jan 2013



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• QA/Sample Management

  • Jun 2005 - Nov 2008

  • Performed Monthly Lab Safety Inspection. • Reported weekly issue in team meeting. • Served on Internal Audit team on monthly basis and as needed. • Effectively used Laboratory Information Management System (LIMS). • Managed Enbrel Bulk Drug Substance and Final Drug Product. • Successfully revised Standard Operation Procedures (SOPs). • Continually maintained sample storage conditions. • Received samples from production. • Documented sample distribution, continually without errors. • Understood and adhered to cGMP practices and principles. • Gowning to production areas per Standard Operation Procedures (SOPs). • Calibrated pipette as needed. • Sampling environmental monitoring. • Aliquot samples by using aseptic technique. • Cross Trained with QAL testing labs. • Disposed of samples according to protocols.