Kelsey M. Kohagura

- Management of Daily Warehouse and Distribution operations across the state of Hawai’i.

- (3) Oahu approx. 150k sqft

- (1) Hilo approx. 50k sqft

- (1) Maui

- (1) Kauai

- Management for DOT commercial fleet (non CDl) (21) vehicles statewide

- Total of 96 employees statewide.

- daily warehouse operations includes, fulfillment, inventory control, loss prevention and mitigation, quality control, and process optimization

- daily distribution operations includes delivery, check in, merchandising and servicing or Military and Grocery accounts.

- Facility and Fleet maintenance.

- management of all logistics and reverse logistics

- management of a oil refinery and processor for food and cosmetics.

- DOT, FDA compliance and system maintenance

- interisland barge and air shipments

- operational budgeting and planning.

- labor budgeting and planning

- WMS and ERP project upgrades and implementation.

- automation projects and projections.

- EDI and ASN transmissions and system maintenance.

Full time till Nov. 2024

Part time Driver / Ops Supervisor from Dec. 2024-Present

- various duties and projects under the direction of the Director of Operations

- Facility Maintenance

- Vehicle Maintenance

- labor planning and scheduling

- Supervision of interior transportation (flight coordinators and checkers)

- Supervision of Pick and Pack for UA, DL, AS, ANZ, AC, AA

- Supervision of the dishroom and daily EQ needs

- Supervision and coordination of transportation and catering schedules

• - 21 CFR 117
• - Oversight of Good Distribution Practices
• - PCQI per FSMA
• - Internal Auditing for Food Safety per FSMA
• - Process development and control to reduce loss from damages
• - Implementation of recouping procedures
• - Damage control and mitigation
• - Process development and review
• - ServSafe certified instructor and proctor
• - Implementation and analysis for packaging lines
• - Corporate sanitarian
• - Regulation and oversight of traceability and recall procedures
• - Complaints processing and investigations
• - Allergen and sanitary programming

• - Contract Operations (COVID-19 Testing: PCR and Antigen)
• - Direction and Management for all COVID-19 testing operations and contracts (C&C Honolulu, HIDoH, HIDoE)
• - Management of All Contract Operators
• - Management of C&C/HNL High Complexity Mobile PCR Testing Lab (COVID-19 Detection)
• - Oversight and management for Interisland Testing Operations (Hawaii Island, Maui, Molokai, Kauai, Oahu)
• - CLIA Compliance for High Complexity and Moderate Complexity Testing (PCR 2 gene detection)
• - Acquisition and Maintenance of CLIA Waived Testing (Lab Director)
• - Management of all Testing personnel for Sample Collection operations and PCR Mobile Lab (All Counties)
• - Compliance to all City and State requests and directive
• - Implementation of all Policy and Procedure for sample collection and sample transport
• - Management of $200K monthly operational budget
• - Reduction of monthly operational expenses from $400k + to $130k (labor included)
• - HIPAA Compliance
• - Operational Budget for collection and testing site
• - Supply acquisition for $2.3m in test kit inventory
• - Management of expense and operational expenditure (Cares Act Reporting)
• - IRS revenue reporting and report filing
• - Management of City Non-Vaccinated Employee Testing Programs
• - Allocation of COVID Testing Assistance to non-profit organizations or other city or state entities
• - Collaboration with outside contractors and applicable officials for state funded community testing programs at multiple sites across Oahu and Maui ($37M allocated to COVID-19 testing)
• - Advisement and consultation for State Travel Programs: Safe Travels Hawaii

• - 21 CFR 117
• - Oversight of Good Distribution Practices for 6 statewide warehouse locations and 1 cash and carry / packing division
• - PCQI per FSMA
• - Internal Auditing for Food Safety per FSMA
• - Process development and control to reduce loss from damages
• - Implementation of recouping procedures
• - Damage control and mitigation
• - Process development and review
• - ServSafe certified instructor and proctor
• - Implementation and analysis for packaging lines
• - Corporate sanitarian
• - Regulation and oversight of traceability and recall procedures
• - Complaints processing and investigations
• - Allergen and sanitary programming

• - Implemented and maintained proper accounting and financial systems following GMP and CFR guidance
• - Maintain and compile annual budgeting and projections
• - Implemented a quality system following 21 CFR 110 compliance
• - Implemented manufacturing systems in accordance to GMP, CFR, OSHA compliance
• - Directed all manufacturing and quality operations and scheduling
• - Directed all quality operations
• - 21 CFR 110 Compliant
• - HACCP compliant
• - Profit and loss and Balance sheet generation and review
• - Directed all sales and marketing operations
• - Document Review and Control
• - Accounts receivables
• - Accounts Payables
• - Invoicing and pricing
• - Procurement of product and supplies
• - Management of facilities and properties
• - Management of Dolce Hawaii- service and supply company
• - Management of Hawaii Rainbow Services- parking/ property management company
• - Quality systems upkeep and maintenance
• - Management of Safety systems for manufacturing and retail locations
• - Account / financial reconciliation for factory operations and retail locations
• - Daily management of wholesale and retail locations

• - Consult on various business projects in Hawaii, Georgia, Tijuana Mx, Sinaloa Mx, Sonora Mx.
• - Project Management
• - Financial consulting
• - ISO 13485, 9001
• - Licensing consultation
• - Medical device Quality systems consultation with foreign companies
• - Consultation on FDA manufacturing guidance and importation internationally
• - Class II device Quality system manufacturing consultation
• - Consultation for validations of process and systems for Nutraceutical and medical devices
• - Customization of processes following 21 CFR 820
• - Importation and US regulation for foreign
• - Nutraceutical Manufacturing process development
• - Consulting for Quality Systems 21 CFR 111
• - Quality system consultation following 21 CFR 110 and 112
• - Receiving and release criteria and procedures
• - Documentation review and release (GDP)
• - Quality and Operational System Implementation and consulting 21 CFR 200
• - QMS and OPS consultation 21 CFR 300
• - GLP and Cleanroom Setup and consultation (ISO)
• - Process development for chemical manufacturing
• - Nutraceutical Product Development and continuous improvement
• - Nutraceutical process development
• - Continuous improvement activities to increase production output
• - US importation consulting
• - Batch/ manufacturing Record implementation and review
• - NSF consulting
• - HACCP consulting
• - CAPA, OOS, RCA Analysis
• - Implementation of specification and release parameters for finished product and raw material
• - Organic and kosher Quality System Consultation
• - cGMP process development and continuous improvement
• - Project Management
• - Third Party Quality and Acquisition Auditing

• - Increased Revenue by 27%
• - Maintained operations for 2 companies (Tensor Surgical and Quantum OPS)
• - Maintain relations with investors and raised capital with different groups in the amounts of $1M-$3M
• - Decreased monthly spending by 66%
• - Implemented employee benefit plans such as Profit Sharing, Medical, dental, vision, 401K, emp. Option
• - Increased production and productivity by 80% by utilizing in house capabilities and brining production of products in house.
• - Implemented Quality systems and QC checks adherent to current regulatory guidance and requirements.
• - Implemented Kaizen , GMP, and 5s for production and business practices
• - Implemented and maintained a GLP Microbiology and Sterilization Laboratory
• - Created, Built, and maintained an ISO5 cleanroom used for sterile processing and packaging
• - Managed Production, Quality, Research, Design, Engineering, Sales and Marketing, Accounting
• - Responsible for Payroll, all accounting, taxes, budgeting, bill pay, Insurance, etc
• - Served as head of Quality (21 CFR 820, 21 CFR 807)
• - ISO 13485, 9001 implementation
• - Maintained CAPA, NCR, QSR, Process FMEA, product complaint and handling
• - Initiated and maintain GMP quality systems for 2 manufacturing process
• - Process development and optimization
• - Quality controls and regulations
• - Implementation and maintenance of Stability Program
• - Experience with 510k Submission
• - Quality Document Review and Approval
• - Manufacturing Documentation Review and Approval
• - Validation of Quality Systems
• - Validation of Manufacturing process
• - Equipment maintenance and validation
• - Conducted internal and external audits
• - Experience with FDA and NSF audits
• - Product sterilization and sustainability
• - Maintained records for design controls
• - Hired as the Operations Manager, 3 months after the board gave me equity in the company, a board seat (Secretary) and promoted me to Director
• - Prepared monthly financials and operational reports for investors and board members
• - Prepared business plans, risk assessments, cost benefit analysis, etc
• - Developed processes and conducted process development exercises
• - Completed a scale up from 6 units every 2 weeks to 30 units every 3 weeks.
• - Basic Knowledge of Machining Units, Processes, materials, engineering and solid works.
• - Maintained public relations with the Mayors office and the Directors of the Chamber

• - Implemented and maintained proper accounting and financial systems following GMP and CFR guidance
• - Maintain and compile annual budgeting and projections
• - Implemented a quality system following 21 CFR 820 compliance
• - Implemented manufacturing systems in accordance to GMP, CFR, ISO compliance
• - Directed all manufacturing and quality operations and scheduling
• - Directed all quality operations
• - 21 CFR 820 compliant
• - cGMP compliant
• - ISO 9001 and ISO 13485 compliant
• - Directed all sales and marketing operations
• - Document Review and Control
• - 510k submission
• - FDA registration for Class I and Class II medical device
• - Oversight of all Machined, non Machined and sterile components
• - Passed Quality audits with Steris, Stryker, and Zimmer
• - Implementation of LEAN, 6s, and Kaizen model systems
• - Kanban, FIFO implementation
• - Responsible for CAPA and RCA documentation and investigations
• - Conducted company wide training for Quality Systems and New operational Protocol
• - Responsible for process and system validation
• - Design Control maintenance and implementation
• - Reduced waste
• - Implemented and maintained stability protocols

• - Experience in Quality and Production systems/ controls for drug product and API production
• - Developed and implemented a chemical production process for a GMP facility (Synthesis, Filtration, Drying, Applications)
• - Process validation
• - Equipment Validation and Maintenance
• - Quality System Validation
• - Assisted in developing a useable quality system which meets cGMP requirements
• - Developed and implemented QC testing and Measurements for chemical intake and release for a GMP facility
• - Optimized API production by 100% and reduced cost by 50% .
• - Process and Assay Development, Process controls and Release and Acceptance Criteria
• - Production Planning, Scheduling, Inventory (Release, raw materials, product), Supply trends
• - Developed an Environmental Bioburden and particulate monitoring and control for a GMP facility and a Class 10,000 clean room.
• - Obtained grants from the FDA and NIH and passed an Orphan Drug use through the Veterinary CVM (FDA).
• - Developed SOP’s, Work Instructions, Master Batch Records, Health and Safety Documentation including MSDS development and use. Produced documents such as OOS, recalls, Deviations, Investigations, CAPA, etc.
• - Proficient on use and training of Scientific Assays such as NMR, FTIR, ICP, SEC MALS, ISE, CHN combustion, Mass Spec. as well as Microbiology Assays and cultures.
• - Proficient on use and training of Production Equipment such as TFF units, Spray Drying, Various Reactors and pumps, Lyophilization, etc.
• - Follow and implement GMP procedures, SOPs and forms as required for the establishment of Quality Management systems (QMS) of the company.
• - Maintain good documentation and records under the quality management system
• - Monitor daily QA activities in the warehouse and Manufacturing Floor
• - Review and document test methods, deviations, investigations, change controls, Certificates of Analysis, protocols and reports
• - Review Bill of Materials, completed batch records, testing records.
• - Review and organize product labels to maintain compliance
• - Review release of raw materials and finished products
• - Coordinate with third party testing laboratories for science-based testing activities.
• - Good Documentation Practices compliance and Implementation
• - Make recommendations for improvements in all processes
• - Implement and monitor effectiveness of CAPAs
• - Experience with FDA, USP, ASTM, ISO, cGMP and GMP regulations and environments
• - Moved a GMP production Facility from Honolulu Hawaii to Claremont California
• - Document control and Writing. Documents include, IQ/OQ/PQ, PM, SOP’s, WI’s, for both Production and quality equipment and processes.
• - Process Validation
• - In house audits (Quality and Production), GMP, Process, and assay training
• - Manage all Facility/ Production Operations: Receiving (Raw Materials), Processing, Manufacturing of API, Manufacturing of Products, Packaging, Shipping, stability and controls, release

Veterinary Technology

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