Co-manufacturer of CPG Food and Ingredients.Responsible for the following activities:• Responsible for all Quality Assurance, Quality Control, Regulatory Compliance for Food Products• Regulatory Compliance (FDA, USDA NOP, Halal, Kosher, Non-GMO, Gluten Free, RSPO)• Quality Management System• Food Safety Programs• Food Safety Plans• Specification Development• Training programs• Internal Audit• Supplier Quality and Approval• Laboratory Management• SQF Practitioner• PCQI Accomplishments:• Updated Food Safety Policy Manual to bring operations into compliance with SQF and the Food Safety Modernization Act• Lead company to SQF Certification-Excellent Rating while expanding the scope of the audit to an additional facility• Developed and implemented supplier approval process• Reorganized quality file manager to increase efficiency• Standardized documents through the development of templates• Designed and implemented a comprehensive Environmental Monitoring program including implementation of Enviromap program • Organized and added structure to CAPA system including design and implemented of customized database• Developed and implemented cleaning validation protocols for processing lines• Successfully lead company through audits including: SQF, BRC, AIB, FDA, Kosher (OU), Organic (QAI, Organic Certifiers), RSPO, and Gluten-Free (GFCO, GFCP).• Lead company through 3 supplier recalls• Worked with Pest Control service provider to provide automated trending to all plants. • Lead organization in development of a master calibration plan.• Developed comprehensive Master Sanitation Schedule

Food and Pharmaceutical IngredientsResponsible for the following activities:• All compliance, quality and food safety activities• Laboratory management• Kosher/Halal/Organic programs• Approved Supplier program• cGMP/HACCP implementation and training• Vendor Food Safety Audits and approvals• Plant calibration program• Root cause complaint investigations and resolutions• Regulatory activities and audits witn regards to FDA compliance• Product development• Internal audit scheduling and processes• Development of product specifications• Contract laboratory management• Product technical queries• Complaint investigation and resolution• Plant SQF PractitionerAccomplishments:• Wrote Quality and Food Safety Manual and lead team to SQF Level 2 Certification (Excellent Rating)• Developed on-line document repository• Developed and implemented MS Access based CAPA log• Implemented Internal Audit protocol• Documented laboratory methods• Identified root cause for several historical quality issues.• Brought Recall program in compliance with FDA regulations• Implemented compliance with the Food Safety Modernization Act• Developed and implemented plant sampling plan.• Developed and implemented raw material purchasing specifications.

Dairy Ingredients Build and implement U.S. based quality and food safety systems from port to customer.Customer complaint managementProvide disposition on On-hold stockQuality documentation managementPerform supplier quality and food safety approval audits.Provide regulatory support for customers and suppliers.Implement continuous improvement initiatives.Collaborate with 3rd party manufacturers to meet product specifications.Create technical/quality procedures where needed

Powders, tablets, and lozenge productsResponsible for the following activities: • Quality Control Laboratory and personnel• Sanitation Program• Pest control• Root cause deviation investigations.• All regulatory activities and audits in regards to FDA and USDA.• Co-Packer compliance to cGMPs and FDA regulations.• Developing, approving and implementing SOPs and maintaining cGMPs. • Review and approval of food, OTC, and dietary supplement labels.• Internal audit scheduling and processes• Development of product specificationsAccomplishments• Created and implemented new HACCP programs.• Created environmental monitoring program.• Developed analytical methods for new products.• Performed plant-wide cGMP training.• Using SPC was able to reduce quality deviations on several product lines.• Created Master Validation Plan for all plant activities.• Updated customer complaint, recall, and mock recall procedures.• Created CAPA program.• Developed and performed process validation (IQ, OQ, PQ) on several processes.• Developed plant sanitation schedules• Developed cleaning validation plans for several process lines. • Created Internal cGMP and Food Safety Audit protocols.• Implemented new cGMPs for Dietary Supplements.• Responsible for review and approval of food, OTC, and dietary supplement labels.• Successfully gained USDA Organic certification.• Received an Excellent rating on AIB audit.• Implemented procedures to fully comply with 21CFR211.• Initiated new product stability program. • Created Quality Manual.• Implemented critical process parameters to reduce quality deviations. • Created and implemented MSAccess-based LIMS system. Training• HACCP Certified (2008)• Safe Quality Food (SQF) Implementation (2008)