Experience

SNBL

• Japan
• Biotechnology Research
• 1 - 100 Employee

• QA Auditor

  • Sep 2012 - Present



Covance Laboratories Inc

• Senior Quality Assurance Auditor

  • Feb 2012 - Jul 2012

  Performs protocol, data, report, and in-lab phase inspections for Toxicology and Dose Analysis disciplines to verify conformance to applicable SOP and regulatory requirements. Performs internal supplemental audits of Toxicology and Dose Analysis disciplines to verify that facility records (e.g., equipment, training files) are in conformance to applicable SOP and regulatory requirements. Serve as the primary client contact for specific client visits. Hosting clients visits including tours. records research, data review, debriefs, and visit follow-up. Participates as a team member in Six Sigma projects (e.g., Reduction of Toxicology Animal Operations data review rejections) Lead and present Good Laboratory Practices Training for new employees. Mentor and train fellow auditors in the Toxicology and Dose Analysis auditing disciplines. SOP administrator for the QAU. Ensuring that updated SOPs are reviewed by the QAU and documented appropriately and in a timely manner. Show less

• Quality Assurance Auditor II

  • Nov 2010 - Mar 2012

  Performed protocol, data, report, and in-lab phase inspections for Toxicology, Dose Analysis and Immunochemistry disciplines to verify conformance to applicable SOP and regulatory requirements. Performed internal supplemental audits of Toxicology, Dose Analysis, and Immunochemistry disciplines to verify that facility records (e.g" equipment, training files) are in conformance to applicable SOP and regulatory requirements. Co-host client visits including visit preparation, involvement in introductions, tours, records research, data review, and debriefs. Participated as a team member for Six Sigma projects (e.g. Process Walk updating and streamlining the process for documentation of TB testing by Animal Operations) Mentor new employees in the toxicology and dose analysis auditing disciplines. SOP administrator for the QAU. Ensuring that updated SOPs are reviewed by the QAU and documented appropriately and in a timely manner. Lead and present Good Laboratory Practices Training for new employees. Show less

• Sample Collection Technician

  • Jul 2007 - Nov 2010

  Performed collection of blood samples and documentation of collected samples. This included processing and documentation of the blood samples drawn for storage and shipment. Responsible for setting up materials for incoming studies and collection of raw data. Pertinent data included animal observations, test material administration and clinical sample collections. Ensured that studies Complied with appropriate standard operating procedures (SOPs), the Good Laboratory Practices (GLPs), and regulatory agency guidelines. This included monitoring animal health, humane restraint, euthanasia of laboratory animals, and collection of biological samples. Responsible for compliance with the Association for Assessment and Accreditation of Laboratory Animal Care International. Participated as a team member in Six Sigma projects (e.g. Sample Storage in Non Clinical Safety Assessment) Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Scientist - Necropsy

  • Feb 2006 - Jul 2007

  Tissue trimming for histology Wet tissue archiving Necropsy study monitor Rodent euthanasia and blood collection. Tissue trimming for histology Wet tissue archiving Necropsy study monitor Rodent euthanasia and blood collection.



West Road Animal Hospital

• Lead Veterinary Technician

  • Dec 2001 - Apr 2007

  Responsible for inventory control and controlled substances automated prescription system. Technical Staff Training Collection of radiographs and biological samples. Surgical assistance including performing dental prophys. Diagnostic lab work On-call emergency technician Responsible for inventory control and controlled substances automated prescription system. Technical Staff Training Collection of radiographs and biological samples. Surgical assistance including performing dental prophys. Diagnostic lab work On-call emergency technician