Experience

Symphony Clinical Research

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager, Quality Systems

  • Apr 2019 - Present

• Quality Systems Analyst

  • Aug 2018 - Apr 2019



Baxter International Inc.

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

• Global Product Surveillance Quality Associate I

  • Jul 2013 - May 2018

  • Assisted FCA with phone calls to patients and customers regarding various recalls on products • Extensive product knowledge in Renal, Elastomeric, Access, IVT Disposable, Therapeutic products, Infusion Pumps, Baxa and BioSurgery complaint handlingo Review and analyze global files for reportable events to the FDAo Proficient in utilizing procedures to determine reportability of complaints for FDA reporting purposes o Working knowledge of 21 CFR 803, 806, 811 and 820… • Assisted FCA with phone calls to patients and customers regarding various recalls on products • Extensive product knowledge in Renal, Elastomeric, Access, IVT Disposable, Therapeutic products, Infusion Pumps, Baxa and BioSurgery complaint handlingo Review and analyze global files for reportable events to the FDAo Proficient in utilizing procedures to determine reportability of complaints for FDA reporting purposes o Working knowledge of 21 CFR 803, 806, 811 and 820 o Investigating information in complaint files for accuracy and completeness o Ensuring MedWatch and FAR reports are submitted in a timely matter o Communicating and creating relationships with international complaint owners and manufacturing facilities to provide the utmost accurate information to the FDAo Training international complaint handlers and engineer’s on how to perform investigations and document the information in the databaseo Assisting in developing plans to investigate identified riskso Participating in continuous improvement efforts and projectso Mentor for new hires: provide product, complaint handling, and workflow management training for hospital productso Analyze reports for the team to address inconsistences and correctionso Created a global work instruction for hospital productso Subject Matter Expert for TrackWise 8 platformo Assist other Global Field Surveillance teams: cross trained in all areas of the department Show more Show less