Quality Assurance / Food Safety Manager with 15 years lab experience. Extensive background in FDA and USDA regulated food, pharmaceutical, and dietary supplement industries.
Manages the quality control department. Has 12 direct reports including 2 supervisors, 3 lab techs, and 7 QC technicians. SQF Practitioner and HACCP team coordinator. Lead support for internal and external audits. Organizes company calibration program. Provides subject matter expertise on statistical process control and liquid nitrogen freezing.
Managed the quality control laboratory. Supervised 2 lab technicians. Manged the installation and commissioning of a liquid nitrogen freeze tunnel. Provided subject matter expertise on statistical process control and PLC programming.
Supported continuous improvement of Quality Systems in a pharmaceutical manufacturing facility; reviewed and approved SOPs, batch records, and analytical test records; performed investigations of deviations from procedures; implemented corrective and preventative actions; has a comprehensive knowledge of agency regulatory requirements (FDA, EU, TGA.)
Performed microbiology and chemistry testing for a pharmaceutical manufacturing facility. Supervised 3 lab technicians. Assisted in FDA audits and regulatory compliance.
Designed and operated a quality control microbiology testing laboratory. Supervised 5 lab technicians. Performed analytical chemistry testing. Helped to implement FDA standards for dietary supplements. Wrote raw material specifications and SOPs.
Assisted in the research of sodium channel regulation using molecular biology and cell culture techniques.
Manufactured sterile injectable pharmaceutical products in a class 100 clean room environment.
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