Experience

Rad Source Technologies

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Specialist

  • Jan 2016 - Present

  Suwanee



WuXi AppTec

• China
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Reporting Analyst

  • Jul 2015 - Jan 2016

  Marietta, GA Perform thorough Quality Assurance reviews of sample processing records.



CryoLife, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Field Assurance Associate

  • May 2014 - Jan 2015

  Kennesaw, GA Performed in-depth investigations into product-related customer complaints for medical devices and human tissue products. Collaborated with surgeons, medical professionals, sales representatives, and CryoLife subject matter experts to ensure accurate and thorough investigations. Managed the daily functions necessary to maintain compliance to the regulatory requirements of complaint investigations from complaint inception to closure. Analyzed reports filed by various departments for… Show more Performed in-depth investigations into product-related customer complaints for medical devices and human tissue products. Collaborated with surgeons, medical professionals, sales representatives, and CryoLife subject matter experts to ensure accurate and thorough investigations. Managed the daily functions necessary to maintain compliance to the regulatory requirements of complaint investigations from complaint inception to closure. Analyzed reports filed by various departments for accuracy and congruency. Completed regulatory reporting activities to ensure compliance with state, federal, and international adverse event reporting requirements Performed root cause analysis to determine possible deviations in cGMP, cGTP, and Quality System Requirements.

• Human Tissue Quality Assurance Associate

  • May 2011 - May 2014

  Kennesaw, GA Performed Quality Assurance reviews of processing records, batch records, and equipment monitoring records generated by the Human Tissue Processing Lab. Ensured that all tissue products were properly identified, controlled, and met all required quality specifications prior to their release for distribution. Provided critical information and strategies to superiors, coworkers, and interdepartmentally to facilitate workflow planning and document revision. Coordinated and performed dry… Show more Performed Quality Assurance reviews of processing records, batch records, and equipment monitoring records generated by the Human Tissue Processing Lab. Ensured that all tissue products were properly identified, controlled, and met all required quality specifications prior to their release for distribution. Provided critical information and strategies to superiors, coworkers, and interdepartmentally to facilitate workflow planning and document revision. Coordinated and performed dry shipper inspection and testing, as well as other Quality Control functions, such as filter integrity testing, autoclave inspection & performance verification, and label verifications. Lead audits of tissue inventories and completed Non-Conformance investigations.

• R&D Laboratory Aide

  • Aug 2010 - Apr 2011

  Kennesaw, GA Conducted equipment monitoring and maintained laboratory supplies in a GLP setting in accordance with SOPs under minimum supervision. Maintained and audited the tissue tracking and chemical inventory databases,