Experience

ADMA Biologics, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Quality Assurance

  • Jan 2017 - Present

• Quality Assurance Product Release

  • Jan 2017 - Present

  Manage and coordinate Product Release department activities. Responsible for Quality related functions that directly support and oversee manufacturing, Packaging, and CMOs. Thorough and timely review of Production and Quality Control records for determination of disposition in adherence with cGMP requirements and support timely shipment of products to the customers. Continuing support for all Environmental Health and Safety (EHS) activities. Review and approval of Quality Systems (Deviations… Show more Manage and coordinate Product Release department activities. Responsible for Quality related functions that directly support and oversee manufacturing, Packaging, and CMOs. Thorough and timely review of Production and Quality Control records for determination of disposition in adherence with cGMP requirements and support timely shipment of products to the customers. Continuing support for all Environmental Health and Safety (EHS) activities. Review and approval of Quality Systems (Deviations, Corrective and Preventive Actions (CAPA), Change Controls, and Product Quality Complaints).



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance Associate Specialist

  • May 2008 - Dec 2016

  Responsible for the Quality Operations related functions that directly support the IPT (Integrated Process Team) for Production Planning, Manufacturing, Filling, Label/Packaging, and process improvement projects. Review and approval of Change Controls, processes, and vendors related investigations, assessing product impact and effective corrective actions. Providing the Quality perspective for troubleshooting, and quality oversight/evaluation for inspection protocols. Assisting with Customer… Show more Responsible for the Quality Operations related functions that directly support the IPT (Integrated Process Team) for Production Planning, Manufacturing, Filling, Label/Packaging, and process improvement projects. Review and approval of Change Controls, processes, and vendors related investigations, assessing product impact and effective corrective actions. Providing the Quality perspective for troubleshooting, and quality oversight/evaluation for inspection protocols. Assisting with Customer complaint investigations. Ensuring compliance with regulatory and procedural requirements through internal quality monitoring/audits. Annual Product Quality Reviews. Batch Production Record review and final product disposition for approved markets. Direct involvement with safety initiatives as a member of the EHS leadership team (Environmental Health and Safety) to promote a safe and efficient work environment. Show less Responsible for the Quality Operations related functions that directly support the IPT (Integrated Process Team) for Production Planning, Manufacturing, Filling, Label/Packaging, and process improvement projects. Review and approval of Change Controls, processes, and vendors related investigations, assessing product impact and effective corrective actions. Providing the Quality perspective for troubleshooting, and quality oversight/evaluation for inspection protocols. Assisting with Customer… Show more Responsible for the Quality Operations related functions that directly support the IPT (Integrated Process Team) for Production Planning, Manufacturing, Filling, Label/Packaging, and process improvement projects. Review and approval of Change Controls, processes, and vendors related investigations, assessing product impact and effective corrective actions. Providing the Quality perspective for troubleshooting, and quality oversight/evaluation for inspection protocols. Assisting with Customer complaint investigations. Ensuring compliance with regulatory and procedural requirements through internal quality monitoring/audits. Annual Product Quality Reviews. Batch Production Record review and final product disposition for approved markets. Direct involvement with safety initiatives as a member of the EHS leadership team (Environmental Health and Safety) to promote a safe and efficient work environment. Show less



Coca-Cola

• Hollywood, Florida

• Quality Assurance Technician

  • Aug 2003 - May 2008

  Conduct qualitative and quantitative testing of water, beverages, syrups, and raw materials throughout the entire production process, ensuring products and packaging meets standards. Responsible for blending syrup batches for multiple flavors, including Carbonated, Non-Carbonated Beverages. Calibration of equipment used for the analysis of the water, sugar, and diet products. Microbiology sampling for the water, minerals salts, syrups, sensitive products, and CIP water. Work in partnership with… Show more Conduct qualitative and quantitative testing of water, beverages, syrups, and raw materials throughout the entire production process, ensuring products and packaging meets standards. Responsible for blending syrup batches for multiple flavors, including Carbonated, Non-Carbonated Beverages. Calibration of equipment used for the analysis of the water, sugar, and diet products. Microbiology sampling for the water, minerals salts, syrups, sensitive products, and CIP water. Work in partnership with other departments to meet productivity and quality goals. Applying cGMP in daily activities. In addition, establishing standards for all quality procedures. Conduct quality package inspections and quality audits. Show less Conduct qualitative and quantitative testing of water, beverages, syrups, and raw materials throughout the entire production process, ensuring products and packaging meets standards. Responsible for blending syrup batches for multiple flavors, including Carbonated, Non-Carbonated Beverages. Calibration of equipment used for the analysis of the water, sugar, and diet products. Microbiology sampling for the water, minerals salts, syrups, sensitive products, and CIP water. Work in partnership with… Show more Conduct qualitative and quantitative testing of water, beverages, syrups, and raw materials throughout the entire production process, ensuring products and packaging meets standards. Responsible for blending syrup batches for multiple flavors, including Carbonated, Non-Carbonated Beverages. Calibration of equipment used for the analysis of the water, sugar, and diet products. Microbiology sampling for the water, minerals salts, syrups, sensitive products, and CIP water. Work in partnership with other departments to meet productivity and quality goals. Applying cGMP in daily activities. In addition, establishing standards for all quality procedures. Conduct quality package inspections and quality audits. Show less



PROPAL S.A.

• Colombia
• Paper and Forest Product Manufacturing
• 200 - 300 Employee

• production/ Lab Technician

  • Aug 1995 - Jan 2000

  Paper manufacturing company. Processing sugar cane bagaze for the production of high quality paper. Paper manufacturing company. Processing sugar cane bagaze for the production of high quality paper.