Quality Control Supervisor

• May 2021 - Present

Quality Assurance Manager

• Apr 2020 - Apr 2021

Site Microbiologist , Microbiology Lab Manager

• Jun 2019 - Apr 2020

Manage a microbiology laboratory and responsible for reducing the site’s risk of micro contamination. Planning and executing of Proficiency test, achieving microbiology lab certification for new testing in house. Train and supervise 3 laboratory technicians, minimizing the false positive samples in 90%. Monitoring execution of area’s procedures including cleaning, calibration and other tasks. Changing microbiology laboratory workflow, increasing 40% of efficiency Provide… Show more Manage a microbiology laboratory and responsible for reducing the site’s risk of micro contamination. Planning and executing of Proficiency test, achieving microbiology lab certification for new testing in house. Train and supervise 3 laboratory technicians, minimizing the false positive samples in 90%. Monitoring execution of area’s procedures including cleaning, calibration and other tasks. Changing microbiology laboratory workflow, increasing 40% of efficiency Provide support for all related micro and environmental third party audit Provide sales support with customer’s micro testing requirements Member of the internal audit Team Manage the OOS finding, identifying root cause and corrective action. Responsible for the environmental monitoring of the Plan Show less Manage a microbiology laboratory and responsible for reducing the site’s risk of micro contamination. Planning and executing of Proficiency test, achieving microbiology lab certification for new testing in house. Train and supervise 3 laboratory technicians, minimizing the false positive samples in 90%. Monitoring execution of area’s procedures including cleaning, calibration and other tasks. Changing microbiology laboratory workflow, increasing 40% of efficiency Provide… Show more Manage a microbiology laboratory and responsible for reducing the site’s risk of micro contamination. Planning and executing of Proficiency test, achieving microbiology lab certification for new testing in house. Train and supervise 3 laboratory technicians, minimizing the false positive samples in 90%. Monitoring execution of area’s procedures including cleaning, calibration and other tasks. Changing microbiology laboratory workflow, increasing 40% of efficiency Provide support for all related micro and environmental third party audit Provide sales support with customer’s micro testing requirements Member of the internal audit Team Manage the OOS finding, identifying root cause and corrective action. Responsible for the environmental monitoring of the Plan Show less

QA/QC Manager

• Jun 2018 - Jun 2019

Responsible for the Implementation and maintenance of the Quality Safety System. Maintained SQF level 2 documentation Manages Client and third part audit Manages facility’s Quality Team members HACCP Team Leader Conduct safety assessments of new or modified manufacturing processes used in the production of foods Review scientific and legal document to ensuring compliance with new regulations In charge of GMP ‘s and Food Safety Training. Perform scientific evaluations… Show more Responsible for the Implementation and maintenance of the Quality Safety System. Maintained SQF level 2 documentation Manages Client and third part audit Manages facility’s Quality Team members HACCP Team Leader Conduct safety assessments of new or modified manufacturing processes used in the production of foods Review scientific and legal document to ensuring compliance with new regulations In charge of GMP ‘s and Food Safety Training. Perform scientific evaluations and reviews of food to evaluate the safety of the product. Manage Organic certification Manage Non GMO project verification. Supervise the Sanitation Program Manage the internal Audit Program. Provide Technical supervision to accomplish Food safety goals Evaluate Microbiological Risk contamination Manage allergen Program. Responsible for customer questionnaire ‘s response Show less Responsible for the Implementation and maintenance of the Quality Safety System. Maintained SQF level 2 documentation Manages Client and third part audit Manages facility’s Quality Team members HACCP Team Leader Conduct safety assessments of new or modified manufacturing processes used in the production of foods Review scientific and legal document to ensuring compliance with new regulations In charge of GMP ‘s and Food Safety Training. Perform scientific evaluations… Show more Responsible for the Implementation and maintenance of the Quality Safety System. Maintained SQF level 2 documentation Manages Client and third part audit Manages facility’s Quality Team members HACCP Team Leader Conduct safety assessments of new or modified manufacturing processes used in the production of foods Review scientific and legal document to ensuring compliance with new regulations In charge of GMP ‘s and Food Safety Training. Perform scientific evaluations and reviews of food to evaluate the safety of the product. Manage Organic certification Manage Non GMO project verification. Supervise the Sanitation Program Manage the internal Audit Program. Provide Technical supervision to accomplish Food safety goals Evaluate Microbiological Risk contamination Manage allergen Program. Responsible for customer questionnaire ‘s response Show less

QA/QC Manager

• Jun 2016 - Jun 2018

Responsible for the operation of the quality control and management of the QMS Train and supervise 4 laboratory technicians HACCP Team member Perform scientific evaluations and reviews of food to evaluate the safety of the product. Manage Internal audit program Manage Non-conforming product, Corrective action and Preventive action Manage certification audit FSCC 22000 Conduct safety assessments of new or modified manufacturing processes used in the production of… Show more Responsible for the operation of the quality control and management of the QMS Train and supervise 4 laboratory technicians HACCP Team member Perform scientific evaluations and reviews of food to evaluate the safety of the product. Manage Internal audit program Manage Non-conforming product, Corrective action and Preventive action Manage certification audit FSCC 22000 Conduct safety assessments of new or modified manufacturing processes used in the production of Yeast Manage Quality Manual System Manage Quality Control and positive release program Implementation of Pathogen Laboratory Prepare guidelines related to the safety and hazard of food products Manage Environmental monitoring program Manage Customer Complain program Show less Responsible for the operation of the quality control and management of the QMS Train and supervise 4 laboratory technicians HACCP Team member Perform scientific evaluations and reviews of food to evaluate the safety of the product. Manage Internal audit program Manage Non-conforming product, Corrective action and Preventive action Manage certification audit FSCC 22000 Conduct safety assessments of new or modified manufacturing processes used in the production of… Show more Responsible for the operation of the quality control and management of the QMS Train and supervise 4 laboratory technicians HACCP Team member Perform scientific evaluations and reviews of food to evaluate the safety of the product. Manage Internal audit program Manage Non-conforming product, Corrective action and Preventive action Manage certification audit FSCC 22000 Conduct safety assessments of new or modified manufacturing processes used in the production of Yeast Manage Quality Manual System Manage Quality Control and positive release program Implementation of Pathogen Laboratory Prepare guidelines related to the safety and hazard of food products Manage Environmental monitoring program Manage Customer Complain program Show less

Quality Division Director

• Mar 2013 - Jun 2016

Responsible for the coordination of the quality control in Alpha Biosciences and the companies affiliated. Responsible for the management of Alpha Biosciences quality control and research and development. Responsible for coordinating with the companies to put in place the best performance and the best cost efficient of the company products. Description of representative activities performed: • Direct and supervise the microbiology laboratory. • Review and evaluate the microbiological… Show more Responsible for the coordination of the quality control in Alpha Biosciences and the companies affiliated. Responsible for the management of Alpha Biosciences quality control and research and development. Responsible for coordinating with the companies to put in place the best performance and the best cost efficient of the company products. Description of representative activities performed: • Direct and supervise the microbiology laboratory. • Review and evaluate the microbiological quality of products. • Interface with FDA inspectors regarding compliance with medical device regulation. • Interface with ISO 9001 auditors to compliance with the ISO certification. Also provide technical support during customer’s audit regarding quality aspect. • Direct all incoming raw materials and in process quality testing. • Review protocols, records and report findings with statistical analysis • Provide the approval formulation for final production. • Review scientific data to determine the appropriateness of testing for products of the company. • Analyze studies that are designed to demonstrate microbial level. • Provide support to quality assurance manager on ISO, FDA and customer’s audit. • Auditor of manufacturing practices. • Advise management of problem developing with scientific area of expertise. • Provide and approve all product labels using in Alpha Biosciences. • Create, update and review standard operation procedures, assay procedures, product label, certificates of analysis and manufacturing procedures in accordance with GMP’s, FDA regulations, and USP. • Provide extensive technical support to Sales and Marketing, Manufacturing, Quality Control and Quality Assurance in the development of new products, problem resolution with product performance, and customer complaints

Quality Control Manager

• Nov 2009 - Mar 2013

Responsible for the quality control and the development of new and improved products of Alpha Bioscience. Responsible for providing technical support to operations ,sales and marketing. Description of representative activities performed: • Review microbiological studies related to the microbiological efficiency of the company’s products. • Advise on microbiological data and release recommendations. • Consult on scientific methodologies and data. • Assess microbiological control… Show more Responsible for the quality control and the development of new and improved products of Alpha Bioscience. Responsible for providing technical support to operations ,sales and marketing. Description of representative activities performed: • Review microbiological studies related to the microbiological efficiency of the company’s products. • Advise on microbiological data and release recommendations. • Consult on scientific methodologies and data. • Assess microbiological control procedures. • Participate in continuing review of technical and scientific literature. • Write SOP’s, assay procedures, product label, Certificates of Analysis, manufacturing procedures in accordance with GMP’s, FDA regulations, and USP. • Prepare summaries of recommendation and conclusion on testing of the finished products. • Provide technical support to Sales and Marketing, Manufacturing, Quality Control and Quality Assurance in the development and approval of new products, problem resolution with product performance, and customer complains.

QC Microbiologist

• May 2005 - Nov 2009

Responsible for the development of all new and improved products. Also responsible for providing technical support to production, sale and marketing. Description of representative activities performed: • Responsible for all microbiological testing of raw material and media production. • Evaluate the control of microbiological population by disinfection and other methods. • Review the protocols of quality control procedures. • Provide technical support to Sales and Marketing… Show more Responsible for the development of all new and improved products. Also responsible for providing technical support to production, sale and marketing. Description of representative activities performed: • Responsible for all microbiological testing of raw material and media production. • Evaluate the control of microbiological population by disinfection and other methods. • Review the protocols of quality control procedures. • Provide technical support to Sales and Marketing, Manufacturing, Quality Control and Quality Assurance in the development of new products, problem resolution with product performance, and customer complaints. • Acquainted with MSDS generation and Product Information Sheets.

Research Assistant

• Nov 2004 - Apr 2005

Responsible for the development of new protein. Also responsible for laboratory maintenance. Description of representative activities performed: • Production of several proteins, as F1, S100B, LcrV. • Perform purification and validation of recombinant expressed proteins • Biochemical characterization of proteins by standard laboratory techniques (e.g. SDS-PAGE, Western Blot, Protein estimation, Flexstand system) as well as more Responsible for the development of new protein. Also responsible for laboratory maintenance. Description of representative activities performed: • Production of several proteins, as F1, S100B, LcrV. • Perform purification and validation of recombinant expressed proteins • Biochemical characterization of proteins by standard laboratory techniques (e.g. SDS-PAGE, Western Blot, Protein estimation, Flexstand system) as well as more

Research and Development. Microbiology

• Jun 2003 - Nov 2004

Responsible for the development of new and improve dehydrated culture media. Also responsible for providing technical support to operations and sale/marketing. Description of representative activities performed: • Develop or improve 11 dehydrated culture media products including Oxford Agar. • Develop alternate formulations for 41 products resulting in an annual cost saving of $300 k. • Provide technical support to Sales and Marketing, Manufacturing, Quality Control and Quality… Show more Responsible for the development of new and improve dehydrated culture media. Also responsible for providing technical support to operations and sale/marketing. Description of representative activities performed: • Develop or improve 11 dehydrated culture media products including Oxford Agar. • Develop alternate formulations for 41 products resulting in an annual cost saving of $300 k. • Provide technical support to Sales and Marketing, Manufacturing, Quality Control and Quality Assurance in the development of new products, problem resolution with product performance, and customer complaints. • Write standard operation procedures, assay procedures, certificates of analysis and manufacturing procedures in accordance with GMP’s, FDA regulations, and USP. • Participate in continuing review of technical and scientific literature. • Familiar with MSDS generation and Product Information Sheet Show less Responsible for the development of new and improve dehydrated culture media. Also responsible for providing technical support to operations and sale/marketing. Description of representative activities performed: • Develop or improve 11 dehydrated culture media products including Oxford Agar. • Develop alternate formulations for 41 products resulting in an annual cost saving of $300 k. • Provide technical support to Sales and Marketing, Manufacturing, Quality Control and Quality… Show more Responsible for the development of new and improve dehydrated culture media. Also responsible for providing technical support to operations and sale/marketing. Description of representative activities performed: • Develop or improve 11 dehydrated culture media products including Oxford Agar. • Develop alternate formulations for 41 products resulting in an annual cost saving of $300 k. • Provide technical support to Sales and Marketing, Manufacturing, Quality Control and Quality Assurance in the development of new products, problem resolution with product performance, and customer complaints. • Write standard operation procedures, assay procedures, certificates of analysis and manufacturing procedures in accordance with GMP’s, FDA regulations, and USP. • Participate in continuing review of technical and scientific literature. • Familiar with MSDS generation and Product Information Sheet Show less

Quality Control Manager

• 1999 - 2002

Responsible for the development and supervision of all Department of Quality Control and Laboratory Testing. Description of representative activities performed: • Supervise staff of 54. • Supervise food quality production. • Set up the food laboratory testing • Direct the chemical and microbiological laboratories • Provide training courses on GMP, HACCP • Responsible for vendor’s audit. • Develop the quality system for the company. • Introduce changes in food… Show more Responsible for the development and supervision of all Department of Quality Control and Laboratory Testing. Description of representative activities performed: • Supervise staff of 54. • Supervise food quality production. • Set up the food laboratory testing • Direct the chemical and microbiological laboratories • Provide training courses on GMP, HACCP • Responsible for vendor’s audit. • Develop the quality system for the company. • Introduce changes in food manipulation to improve food safety quality. • Provide expert support to legal department in evaluation of legal customer complains. • Provide professional support to the purchase department in the qualification of new vendors and new products. Show less Responsible for the development and supervision of all Department of Quality Control and Laboratory Testing. Description of representative activities performed: • Supervise staff of 54. • Supervise food quality production. • Set up the food laboratory testing • Direct the chemical and microbiological laboratories • Provide training courses on GMP, HACCP • Responsible for vendor’s audit. • Develop the quality system for the company. • Introduce changes in food… Show more Responsible for the development and supervision of all Department of Quality Control and Laboratory Testing. Description of representative activities performed: • Supervise staff of 54. • Supervise food quality production. • Set up the food laboratory testing • Direct the chemical and microbiological laboratories • Provide training courses on GMP, HACCP • Responsible for vendor’s audit. • Develop the quality system for the company. • Introduce changes in food manipulation to improve food safety quality. • Provide expert support to legal department in evaluation of legal customer complains. • Provide professional support to the purchase department in the qualification of new vendors and new products. Show less

Technical Director

• 1995 - 1999

Responsible for all microbiological and chemical testing performed in the laboratory. Supervised staff of 7. • Interface with the SENASA inspectors regarding compliance with GLP and ISO 25 regulations. • Train staff in microbiological analysis • Develop, evaluate and revise technical standard operation procedures. • Direct and manage all activities at the laboratory. • Train staff in Quality Assurance in microbiological testing laboratories. Responsible for all microbiological and chemical testing performed in the laboratory. Supervised staff of 7. • Interface with the SENASA inspectors regarding compliance with GLP and ISO 25 regulations. • Train staff in microbiological analysis • Develop, evaluate and revise technical standard operation procedures. • Direct and manage all activities at the laboratory. • Train staff in Quality Assurance in microbiological testing laboratories.

Director of Microbiology

• 1993 - 1995

• Train staff in microbiological analysis • Write the Quality Systems Manual • Audit minimarket and food plants • Train personal in GMP regulations • Provide expert support to legal department in the evaluation of legal customer complaints. • Train staff in microbiological analysis • Write the Quality Systems Manual • Audit minimarket and food plants • Train personal in GMP regulations • Provide expert support to legal department in the evaluation of legal customer complaints.