Experience

Hemo bioscience

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

• Manufacturing Manager

  • Apr 2019 - May 2020

  *Manage manufacturing operations and processes *Plan production schedule and relevant resource requirements *Maintain and review batch records *Quality Management Systems (QMS) Support *Manage manufacturing operations and processes *Plan production schedule and relevant resource requirements *Maintain and review batch records *Quality Management Systems (QMS) Support



Baebies

• United States
• Medical Device
• 1 - 100 Employee

• Senior Quality Engineer

  • Dec 2016 - Oct 2018

  Support manufacturing engineering and ensure compliance to production control requirements; GMP review of batch records and quality control test records / Document Development and Compliance management: SOP authoring and updating, protocol review and function-specific contribution, non-conformance material disposition, investigation and deviation analysis, change control management, CAPA investigations; document control within electronic data management systems / Support internal and external… Show more Support manufacturing engineering and ensure compliance to production control requirements; GMP review of batch records and quality control test records / Document Development and Compliance management: SOP authoring and updating, protocol review and function-specific contribution, non-conformance material disposition, investigation and deviation analysis, change control management, CAPA investigations; document control within electronic data management systems / Support internal and external compliance audits / Working knowledge of FDA's Quality System Regulations and ISO 13485 standards Show less Support manufacturing engineering and ensure compliance to production control requirements; GMP review of batch records and quality control test records / Document Development and Compliance management: SOP authoring and updating, protocol review and function-specific contribution, non-conformance material disposition, investigation and deviation analysis, change control management, CAPA investigations; document control within electronic data management systems / Support internal and external… Show more Support manufacturing engineering and ensure compliance to production control requirements; GMP review of batch records and quality control test records / Document Development and Compliance management: SOP authoring and updating, protocol review and function-specific contribution, non-conformance material disposition, investigation and deviation analysis, change control management, CAPA investigations; document control within electronic data management systems / Support internal and external compliance audits / Working knowledge of FDA's Quality System Regulations and ISO 13485 standards Show less



Avioq

• United States
• Biotechnology Research
• 1 - 100 Employee

• Manufacturing Supervisor

  • Aug 2011 - Nov 2016

  Provide Manufacturing supervision for HTLV-I/II components and kits / Provide leadership for Manufacturing work flow and interaction with other departments / Provide leadership in support activities necessary for ISO and cGMP compliance / Provide QA Department assistance with document distribution and internal audits / Manage weekly workload schedule and relevant resource requirements / Provide training to new personnel in a specific processes Provide Manufacturing supervision for HTLV-I/II components and kits / Provide leadership for Manufacturing work flow and interaction with other departments / Provide leadership in support activities necessary for ISO and cGMP compliance / Provide QA Department assistance with document distribution and internal audits / Manage weekly workload schedule and relevant resource requirements / Provide training to new personnel in a specific processes



BioTechnology Transfer (BTT)

• Raleigh, NC

• Consultant

  • 2006 - 2011



bioMérieux

• France
• Biotechnology Research
• 700 & Above Employee

• QC Analyst

  • 2004 - 2006



Pharmanetics, Inc.

• Raleigh, NC

• Senior Research Associate

  • 1994 - 2004



Duke University Medical Center

• Hospitals and Health Care
• 700 & Above Employee

• Medical Technologist

  • 1990 - 1994