Experience

MERIAL LIMITED

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Auditor

  • Sep 2012 - Present

  QA Audit and inspection of clinical studies conducted in the US and internationally to ensure compliance with GCP regulations, Standard Operating Procedures and Merial policies. • Understanding of VICH, EPA/OPPTS, USDA and EMEA/CVMP regulatory compliance. • Knowledge of requirements for studies in submission phases including pivotal dose confirmation, efficacy, multi-site clinical field efficacy, and exploratory PK studies used as supporting data for pivotal submissions… Show more QA Audit and inspection of clinical studies conducted in the US and internationally to ensure compliance with GCP regulations, Standard Operating Procedures and Merial policies. • Understanding of VICH, EPA/OPPTS, USDA and EMEA/CVMP regulatory compliance. • Knowledge of requirements for studies in submission phases including pivotal dose confirmation, efficacy, multi-site clinical field efficacy, and exploratory PK studies used as supporting data for pivotal submissions. • Includes audit of protocols, raw data, statistical input/output files and reports for Canine, Feline, Equine, Bovine (including Dairy), Ovine, and Porcine studies. • Performs GCP in-life phase inspections and GLP in-life critical phase inspections. • Contributes to facility audits and inspections, including SOP reviews. • International Project Team member Show less QA Audit and inspection of clinical studies conducted in the US and internationally to ensure compliance with GCP regulations, Standard Operating Procedures and Merial policies. • Understanding of VICH, EPA/OPPTS, USDA and EMEA/CVMP regulatory compliance. • Knowledge of requirements for studies in submission phases including pivotal dose confirmation, efficacy, multi-site clinical field efficacy, and exploratory PK studies used as supporting data for pivotal submissions… Show more QA Audit and inspection of clinical studies conducted in the US and internationally to ensure compliance with GCP regulations, Standard Operating Procedures and Merial policies. • Understanding of VICH, EPA/OPPTS, USDA and EMEA/CVMP regulatory compliance. • Knowledge of requirements for studies in submission phases including pivotal dose confirmation, efficacy, multi-site clinical field efficacy, and exploratory PK studies used as supporting data for pivotal submissions. • Includes audit of protocols, raw data, statistical input/output files and reports for Canine, Feline, Equine, Bovine (including Dairy), Ovine, and Porcine studies. • Performs GCP in-life phase inspections and GLP in-life critical phase inspections. • Contributes to facility audits and inspections, including SOP reviews. • International Project Team member Show less



Merial

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Specialist III

  • Aug 2007 - Sep 2012

  Conducted on-going quality reviews and/or preparation of study documents using appropriate levels of attention to detail, organizational skills, and understanding of corporate and facility SOPs, VICH guidelines and GLP regulations and guidelines required to achieve approval within Merial and ultimately with the appropriate regulatory agencies for a marketed product. Supervised up to 5 Trial Coordinator.

• QA Associate Auditor

  • Jun 2005 - Aug 2007

  Conducted protocol, critical phase, raw data, and report audits for GCP veterinary pharmaceutical research studies conducted in the US.

• QC Specialist/ Veterinary Research Assistant

  • May 2001 - Jun 2005

  Responsible for providing support and assistance to the clinical staff in the execution and quality control of data capture and reporting functions required in clinical study programs.



MFA Incorporated

• United States
• Farming
• 200 - 300 Employee

• Nutrition Assistant & Regulatory Specialist

  • Dec 1983 - May 2001

  Ration formulation for all species of animals using in-house software. Responsible for feed labeling. Created computerized least-cost livestock feed formulations within nutritionist’s guidelines; Assured adherence of feed formulations, feed labeling, feed mill procedures, and retail facility procedures to FDA GMP’s and State Department of Agriculture feed laws. • Maintained annual FDA licensing of feed mills. • Assured quality of feeds by coordinating regular laboratory… Show more Ration formulation for all species of animals using in-house software. Responsible for feed labeling. Created computerized least-cost livestock feed formulations within nutritionist’s guidelines; Assured adherence of feed formulations, feed labeling, feed mill procedures, and retail facility procedures to FDA GMP’s and State Department of Agriculture feed laws. • Maintained annual FDA licensing of feed mills. • Assured quality of feeds by coordinating regular laboratory analysis of ingredients and/or feeds and applying results to computer feed formulations. • Provided technical support and conducted training sessions for field sales force on nutrition applications. • Key involvement in acquisition, customization, implementation, integration and maintenance of computer software systems used for internal feed formulation and customer ration balancing. This included successful integration with feed pricing software and feed inventory system. • Supervised 1 office clerical personnel. Show less Ration formulation for all species of animals using in-house software. Responsible for feed labeling. Created computerized least-cost livestock feed formulations within nutritionist’s guidelines; Assured adherence of feed formulations, feed labeling, feed mill procedures, and retail facility procedures to FDA GMP’s and State Department of Agriculture feed laws. • Maintained annual FDA licensing of feed mills. • Assured quality of feeds by coordinating regular laboratory… Show more Ration formulation for all species of animals using in-house software. Responsible for feed labeling. Created computerized least-cost livestock feed formulations within nutritionist’s guidelines; Assured adherence of feed formulations, feed labeling, feed mill procedures, and retail facility procedures to FDA GMP’s and State Department of Agriculture feed laws. • Maintained annual FDA licensing of feed mills. • Assured quality of feeds by coordinating regular laboratory analysis of ingredients and/or feeds and applying results to computer feed formulations. • Provided technical support and conducted training sessions for field sales force on nutrition applications. • Key involvement in acquisition, customization, implementation, integration and maintenance of computer software systems used for internal feed formulation and customer ration balancing. This included successful integration with feed pricing software and feed inventory system. • Supervised 1 office clerical personnel. Show less