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Click here or scroll down to respond to this candidateCandidate's Name
Lutherville-Timonium, MD Street Address
EMAIL AVAILABLEPHONE NUMBER AVAILABLE"Results-driven professional with a strong background in quality assurance and regulatory compliance. Accomplished in implementing and maintaining ISO certifications, HACCP principles, and FDA regulations in the food and beverage industry. Proven track record in leading cross-functional teams, conducting training programs, and improving quality control processes. Exceptional skills in contamination detection and elimination. Committed to ensuring product safety and quality. Looking to leverage my expertise to drive excellence in a new role." Work ExperienceBusiness OwnerIODSEPTIC.com - Baltimore, MDJanuary 2016 to Present Led a cross-functional team in the research and development of a novel OTC antiseptic solution. Played a key role in project planning, concept development, and product formulation. Conducted extensive market research and competitive analysis to identify opportunities and gaps in the OTC antiseptic product category. Collaborated with regulatory and quality assurance teams to ensure compliance with relevant standards and regulations. Successfully developed and tested multiple formulations, optimizing the product for safety and efficacy. Managed pilot testing, clinical trials, and user feedback to refine the product's performance. Led the effort to secure necessary approvals and certifications for product launch. Developed marketing strategies and materials for the product launch, including product positioning, labeling, and advertising. Achieved [mention specific achievements, such as meeting or exceeding sales targets, gaining market share, or launching the product in a specific number of retail locations]. QC ManagerWhittier Seafood LLC - Whittier, AKJune 2023 to September 2023 Managed BRC Documentation Updates: Spearheaded the review and update of BRC (British Retail Consortium) documentation, ensuring compliance with industry standards and facilitating successful audits. Oversaw Hygiene Control and Supervision: Implemented and enforced strict hygiene control measures, conducting regular inspections and providing training to staff, resulting in improved product safety and quality. Supervised IPC Machines: Managed the operation and maintenance of In-Process Control (IPC) machines, optimizing production efficiency and minimizing downtime. Supervision of QC Technicians: Led a team of Quality Control (QC) technicians, providing guidance and training to ensure consistent product quality and adherence to quality standards. Whole Plant Sanitization: Developed and executed comprehensive plant sanitization protocols, enhancing sanitation and safety throughout the facility. Environmental Checking: Conducted regular environmental assessments to identify and mitigate potential hazards, contributing to a safer and healthier workplace. Providers Managing: Effectively managed relationships with suppliers and service providers, negotiating contracts and ensuring timely and cost-effective procurement of essential materials and services.Quality Assurance ManagerHalperns USDA certified facility - Baltimore, MDSeptember 2022 to March 2023 Implemented and maintained the Quality Safety System for the facility. Managed and led a team of quality professionals. Served as the HACCP Team Leader, ensuring compliance with food safety standards. Oversaw Good Manufacturing Practices (GMPs) and conducted Food Safety Training. Supervised the Sanitation Program to maintain high hygiene standards. Took responsibility for Pre-op procedures in Meat and Seafood Production. Conducted daily operations monitoring to ensure quality and safety. Developed all new Standard Operating Procedures (SOPs) to meet BRC certification requirements. Managed the Environmental monitoring program to ensure environmental compliance. Oversaw the internal audit program to maintain and improve quality standards. Clinical ScientistCD Laboratories (Zimmer Biomet) - Towson, MDJanuary 2018 to December 2022 Proficient in performing ELISA (Enzyme-Linked Immunosorbent Assay) on Alpha defensin and NE samples, particularly in the context of Synovasure patient fluids. Experienced in conducting multi-bacteria panel testing on MID samples. Skilled in operating and maintaining laboratory equipment, including: Perkin Elmer Liquid Handler Biotek Automatic Plate Washer Biotek Epoch Plate Reader Luminex 200Quality Assurance SpecialistCFR - Columbia, MDMarch 2018 to June 2018 Conducted internal audits to ensure compliance with FDA CFR 820 regulations for medical devices. Identified non-compliance issues and worked with cross-functional teams to implement corrective and preventive actions (CAPAs). Updated and revised Standard Operating Procedures (SOPs) to align with FDA regulations and industry best practices. Collaborated with relevant departments to ensure effective documentation and adherence to quality standards. Maintained and improved the Quality Manual to reflect updated processes and regulatory requirements. Assisted in the preparation for external audits and inspections by regulatory authorities. Successfully implemented quality improvements resulting in [mention specific improvements, e.g., reduced non-compliance incidents, improved process efficiency, or enhanced product quality]. Stayed updated on changes in FDA regulations and ensured that the QMS remained compliant. Quality Assurance SpecialistCFR - Columbia, MDJune 2017 to July 2017 Conducted internal audits to ensure compliance with FDA CFR 820 regulations for medical devices. Identified non-compliance issues and worked with cross-functional teams to implement corrective and preventive actions (CAPAs). Updated and revised Standard Operating Procedures (SOPs) to align with FDA regulations and industry best practices. Collaborated with relevant departments to ensure effective documentation and adherence to quality standards. Maintained and improved the Quality Manual to reflect updated processes and regulatory requirements. Assisted in the preparation for external audits and inspections by regulatory authorities. Successfully implemented quality improvements resulting in [mention specific improvements, e.g., reduced non-compliance incidents, improved process efficiency, or enhanced product quality]. Stayed updated on changes in FDA regulations and ensured that the QMS remained compliant. Quality Assurance ManagerAlpha Biosciences- Medical Device Company (Dehydrated Culture Media Company). - Baltimore, MD May 2013 to May 2016Achievements: Update the whole Quality System per ISO 9001:2008 and perform maintenance of it. Lead problem solving teams to identify root cause of process failure. Responsibilities include: Write SOPs, work instructions, procedure forms, CAPA to send to customers. Quality Representative for External Audits (FDA, ISO, Customers) with excellent outcomes. Improve customer communication that helps solve customer issues and answer questionnaires promptly. Daily approval of finished Goods labels and Filling Events. Review MSDS (material safety data sheets), PMS (product material specification), product information to be provided to customers and raw materials release. Arrangement of external equipment calibration. Statistical validation of the processes (V-Blender, drum mixing). GMP training. Internal audits and management reviews. Audits to supplier on their own site. Cleaning procedures per FDA (Validation of Cleaning Processes (7/93)), and cleaning validations using 3M Clean-Trace NGi Luminometer and 3M ATP swabs. Cleaning procedure: CIP, COP for small mobile parts.Laboratory SupervisorCenter of Vaccine Development-Division of Infectious Diseases and Tropical Pediatrics, Department of Pediatrics, University of Maryland - Baltimore, MD January 2004 to February 2013Achievements: Performance of in depth immunological studies. Responsibilities include: Archival and inventorying of peripheral blood mononuclear cells (PBMC) from subjects Cell proliferation measurements by 3H Thymidine Incorporation. Set up of antigen stimulation assays using Schu-S4, media and SEB for cytokine production measurements, for assessment by multichromatic (10 color) flow Cytometry. Microbiology:Bacteria (E. coli & Salmonella) growth for the preparation of infected target cells by irradiated procedure. Agar plates preparation with and without antibiotic. Research AssistantDepartment of Biomedical Sciences University of Maryland, - Baltimore, MD January 2002 to December 2004PI: Henry Williams; Supervisor: Silvia Pineiro (240) 276-8227 Achievements: Use of Bdellovibrio as predator to eliminate pathogenic gram-negative bacteria. Studies involved environmental samples of Bdellovibrios (a bacterial parasite). Activities included isolation and characterization with API, BBL crystal, prey susceptibility. Responsibilities:Performance of PCR reactions, DNA extraction, FISH essays.General laboratory activities.ConsultantIASSA, Frozen Pizzas (B A - Argentina).January 2000 to December 2002Achievements: Successfully obtained ISO 9002 certification for the company, demonstrating commitment to quality management. Efficiently managed Quality Assurance/Quality Control (QA/QC) activities, ensuring product quality and safety.Responsibilities: Managed training courses for food handlers, providing essential knowledge and skills to maintain food safety standards. Prepared Quality Control manuals compliant with ISO 9002 and Good Manufacturing Practices (GMP) guidelines, streamlining quality processes and ensuring adherence to standards. Conducted microbiological tests using 3M Petrifilm Plates for E. coli, coliform, yeast, and mold, ensuring the safety and quality of food products. Collaborated with cross-functional teams to implement corrective actions based on test results, further enhancing product safety and quality. Maintained accurate records of test results and implemented necessary measures for continuous improvement.ConsultantLarangeira SA, Restaurant chain (B A, Argentina).January 1998 to December 1999Achievements: Instruct the Restaurant employees about optimal conditions of food storage, food handling when cooking, cleaning before cooking and cleaning storage areas. Responsibilities include: Manage training courses for food handlers in restaurants. ConsultantGancia SA, Beverage company (B A - Argentina).January 1998 to December 1999Achievement: Successfully implemented HACCP (Hazard Analysis and Critical Control Points) principles in the beverage production process, enhancing product safety and quality. Responsibilities: Conducted training sessions for production employees on the proper cleaning procedures for machinery and equipment after use, ensuring compliance with hygiene and safety standards. Led contamination detection and elimination efforts, identifying and resolving potential sources of contamination in the production process. Implemented process improvements to prevent new contamination incidents and enhance overall product safety. Collaborated with cross-functional teams to develop and maintain HACCP plans and procedures, continuously monitoring and improving product safety standards. Maintained detailed records of contamination detection and elimination efforts, contributing to a data- driven approach for quality control.Laboratory SupervisorMicrobiticos Certified Laboratory (B A - Argentina). January 1997 to December 1998Responsibilities include: Set up the required standards to analyze bacteria: o Pseudomonas, Salmonella, E. coli, Staphylococcus aureus. o Toxins on food (e.g., histamine). Set up analysis on dairy products according to the FDA protocols. Director of QualityDr. Rapela's Laboratory (B A - Argentina).January 1995 to December 1996Achievements: Certify the laboratory by government agency (SENASA). Responsibilities include: Validation of Foodborne Pathogen detection (Listeria monocytogenes, E. coli 0157:H7, Staphylococcus aureus and Salmonella sp) completing 150 samples e/a. Validation of physical and chemical tests in water (completion of 150 samples) Director of QualityDISCO SA, Supermarket Chain - (B A, Argentina)January 1993 to December 1996Achievements: Improve the routine work of food handlers (hygiene and sanitation as well as the workplace).Responsibilities include: Develop and set up the laboratory of food analysis. Supervise the hygienic condition of premises to make them optimal for food handling. Conduct classical microbiological tests: Escherichia coli 0157:H7, Salmonella, Pseudomonas, Listeria, S aureus, API for biochemical tests. Conduct ELISA tests to analyze hormones such as Clenbuterol and Salbutamol. Conduct Milk and Dairy analysis (yoghurt, cheese, butter, milk powder). Conduct GC, HPLC tests: measurement of pesticides in food (DDT, Aldrin, Dieldrin, Endrin) and Polychlorinated Biphenyl (PCB), methanol in alcoholic beverages and food additives. Provide technical support for quality training to suppliers, as well as technical training in areas of HACCP, microbiological control, sanitation, GMP, and pest control for every one of 55 branches. EducationMaster of Science in Food ChemistrySkills Process validation of manufacturing machines.Experience in HPLC, GC,GMP knowledge with FDA 21 CFR parts 11, 210 and 211. Linkshttp://LINKEDIN LINK AVAILABLECertifications and LicensesHACCP Certification |
