Benjamin Misumi Email and Phone Number
Benjamin Misumi work email
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Benjamin Misumi personal email
Benjamin Misumi is a seasoned quality management professional who immigrated to the United States with a passion for excellence and helping others. Through his experience in the pharmaceutical, food, and supplement industries, he has developed expertise in regulatory compliance, auditing, and implementing Good Manufacturing Practices (cGMP) that align with FDA standards.Benjamin has held key roles at ProCore Pharma, Aegle Nutrition, and Formulife, Inc., where he established quality systems, led successful audits, and provided leadership for regulatory compliance. Driven by his desire to help businesses improve their quality presence, he co-founded Misumi & Windlow, LLC, a consulting firm specializing in cGMP development for FDA-regulated industries.Currently, as Vice President of Quality at TerraPharma Labs Inc. , Benjamin is a member of the executive leadership team, driving quality initiatives and process improvement activities. He leads audits, ensures compliance with FDA regulations, and maintains a culture of quality throughout the organization.Drawing upon his journey and the challenges he has overcome, Benjamin is committed to using his knowledge and experience to help underserved communities achieve their dreams. This dedication is at the heart of his current venture, TerraPharma Labs, where he aims to provide opportunities and support for those who may face barriers to success in the industry.
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Vice President Of QualityTpl Dba Upscale Mfg Solutions Jul 2019 - PresentIrving, Texas, United States- Member of the Executive Leadership Team, driving the development of a quality culture aligned with FDA regulations and cGMP- Partner with company leadership to identify strategies and solutions for quality initiatives, process excellence, and scalable growth- Implement policies, processes, and training improvements to support quality initiatives and monitor Key Performance Indicators- Manage Manufacturing/Product Quality Issues, Corrective and Preventative Actions (CAPA), and lead internal and external quality audit activities- Lead client regulatory agency and certification audits, including FDA, GMP, Informed Choice/Informed - Sports, Organic (Texas Department of Agriculture), Texas Department of Health, and international compliance- Provide leadership for quality and regulatory systems based on CFR 21 FDA regulations and cGMPs- Create and maintain SOPs, batch production records, handle complaints, adverse event reporting, and recall handling- Determine required investigations and corrective actions, track and report quality/regulatory information to management- Maintain regulatory files, documentation, HACCP Program, and Food Defense Program -
PartnerMisumi & Windlow, Llc Mar 2017 - Oct 2021Dallas/Fort Worth AreaMisumi & Windlow, LLC specializes in regulatory compliance, auditing, and cGMP development for FDA-regulated food, beverage, cosmeceutical, and supplement industries. Services include:- Creating, refining, and implementing Quality Management Systems, Standard Operating Procedures, and Good Manufacturing Processes- Assisting manufacturers, brands, and distributors in obtaining certifications such as GMP, NSF, NPA, Organic, and meeting international compliance standards- FDA Regulatory Consulting, Submission, and Auditing Services- USDA/Organic certification and compliance- FSMA Consulting and implementation- Food/Beverage Facility Registration and Auditing Services- Label Compliance-International Compliance -
Director Of QualityFormulife, Inc Jan 2016 - Nov 2019Allen, Tx- Created and maintained company SOPs, batch production records, and master manufacturing records- Provided leadership for quality and regulatory systems based on CFR 21 FDA regulations and cGMPs- Handled complaints, adverse events, and recall handling; determined required investigations and corrective actions- Tracked and reported quality/regulatory information to management; maintained regulatory files, documentation, HACCP Program, and Food Defense Program- Assured proper raw material procurement, developed and maintained Certificates of Analysis (COAs) and production specifications for finished products- Led client and regulatory agency audits (FDA, GMP, USDA, etc.)- Reviewed labeling proofs for compliance, interpreted regulations, and provided consultancy for compliance needs- Reviewed testing and production records, conducted in-process testing- Interfaced with customers, auditors, and others as necessary for quality and regulatory program requirements- Conducted employee training in areas of responsibility, including GMPs -
Senior Quality ManagerAegle Nutrition Feb 2012 - Dec 2015Carrollton, Tx- Established and maintained a quality and environmental system consistent with cGMP standards and customer-specific requirements as Management Representative- Evaluated quality system performance, reviewed goal progress, and ensured compliance of processes, products, materials, and components- Maintained, updated, reviewed, and approved quality documentation and SOPs to reflect current processes- Resolved customer complaints and non-conformances to ensure uninterrupted product flow to customers- Managed QC department projects, work flow, and communication; created efficiencies and improved timelines- Assisted with customer complaint resolutions, maintained regulatory files, documentation, HACCP Program, and Food Defense Program- Developed new products, supplement facts panels, and maintained production specifications and Certificates of Analysis (COAs)- Led client and regulatory agency audits, including FDA, CVS, Texas Health Department, and GMP Certification- Reviewed labeling proofs for compliance, interpreted regulations, and provided consultancy for compliance needs- Conducted employee training in areas of responsibility, including GMPs -
Qa/QcProcore Pharma Apr 2006 - Jan 2012Coppell Tx- Provided support and guidance for QA labs and production areas, assisted with Quality and Sanitation processes- Performed internal and external Micro, Chemistry, and Basic laboratory testing on raw ingredients and finished products to ensure compliance with company and customer specifications- Set and communicated daily goals to quality technicians, recorded sanitation and inspection results- Conducted audits, material safety, and other sanitation projects as required by management- Collaborated with the Director of Quality in writing Standard Operating Procedures (SOPs) and Good Manufacturing Processes (GMPs) for the Quality department- Operated, calibrated, troubleshot, and repaired lab equipment, weighing scales, and other production equipment- Acquired knowledge of all technical work throughout the plant- Managed assembly lines with five to fifteen production workers
Benjamin Misumi Skills
Benjamin Misumi Education Details
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Biology/Biological Sciences.
Frequently Asked Questions about Benjamin Misumi
What company does Benjamin Misumi work for?
Benjamin Misumi works for Tpl Dba Upscale Mfg Solutions
What is Benjamin Misumi's role at the current company?
Benjamin Misumi's current role is Quality VP @ TPL Manufacturing | Investor | Startup Advisor.
What is Benjamin Misumi's email address?
Benjamin Misumi's email address is be****@****ion.com
What schools did Benjamin Misumi attend?
Benjamin Misumi attended The University Of Texas At Arlington.
What skills is Benjamin Misumi known for?
Benjamin Misumi has skills like Microsoft Office, Research, Management, Strategic Planning, Public Speaking, Microsoft Excel, Microsoft Word, Powerpoint, New Business Development, Teamwork, Team Leadership, Fda Gmp.
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