Providing accounting, bookkeeping, & management consulting services to start-ups and small businesses. - Certified QuickBooks Online Advanced ProAdvisor- QuickBooks Online Clean-up & Set-up- Specializes in E-Commerce Accounting, Service Industries, and Start-ups- Bookkeeping services- Monthly financial reporting- Budget and cashflow projections- Accounting Operations workflows and procedure development - Mentor & train internal accounting teams

Developed & implemented operations and finance processes & systems to transition business from start-up phase to operational readiness, including development of all accounting policies and procedures. Major initiatives included monthly financial reporting, cost analysis and forecasting models, contract management, vendor/contractor on-boarding, vendor management systems and metrics, project management system and tools, and qualification of supply chain vendors.

Lead commercialization efforts for the launch of innovative quantum dot nano-material by developing strategic roadmap for commercial operations including cost models, make vs. buy analysis, forecasting, CapEx planning, cost reduction roadmap, EHS/regulatory requirements, and quality management systems.

Zirna Consulting provides consultation services in strategic planning, operations management, and supply chain management.Key Accomplishments- Transformed client's quality management system, training program, and supply chain / materials management system by integrating best practices, value stream mapping, and risk-based methodology in compliance with 21CFR820 regulations and industry standards. - Designed risk-based supplier qualification and supplier performance systems to ensure compliance with FDA regulations.- Developed operational and supply chain strategy for newly constructed FDA regulated facility to align with the client's existing quality infrastructure. Worked closely with internal and external stakeholders and project team to identify and develop critical milestones and timeline for production readiness. Mentored and trained project team throughout implementation and execution phase to ensure on-time delivery of facility and equipment to meet client's customer product needs.-Provided project management and logistic support for medical device pilot study.

-Transformed business, engineering, production, and quality systems from a single client (Pfizer) perspective to systems able to accommodate diverse needs of growing multi-client business.-Implemented and reduced to practice 17 new drug delivery technologies and processes for over 45 products into GMP production for Pfizer to support clinical and regulatory GLP tox studies.-Led business development activities and RFP process with new clients requesting GMP materials. -Developed outsourcing strategy to broaden overall supply chain service offerings. Performed due diligence process and technical evaluation for companies that best aligned with cultural fit. -Created key metrics/KPI's for GMP division to evaluate overall performance and assist in development of individual and department goals and objectives.-P&L ownership. Reviewed and approved month end financials (P&L, balance sheet, cash flow projections), maintained 12-month proforma and cash flow analysis, developed annual and capital budgets. -Created custom forecasting model to evaluate 10-year growth scenarios to assess P&L, human capital, facility and equipment capital, and associated cash flow and investment projections.

-Oversaw all daily operations of the cGMP manufacturing division including ownership of master production schedule, equipment and maintenance schedules, materials management, resource planning, and coordination with all departments. -Established and implemented New Product Introduction (NPI) system (also known as technology transfer) to ensure proper evaluation of equipment, materials, and technical specifications for new products, of which 95% were custom.-Governed strategic partnership with Pfizer Clinical Supply Chain.-Initiated strategic sourcing initiatives for new technologies. Collaborated with engineers and sourcing personnel to ensure materials and equipment met cGMP specifications. -Managed all client relationships to ensure on-time delivery. Prepared quotes, communicated status and schedule, and discussed any upcoming future needs. -Developed capital budget and resource needs for capital projects. -Assisted with overseeing daily financial performance and forecasting. -Participated as technical and operational expert in all client quality and regulatory audits.

-Oversaw the transfer of all new products and technologies in collaboration with R&D and production to ensure successful first time manufacture by coordinating with scientists and engineers during development life cycle.-Managed projects that required identification, installation, and commission of new process equipment including associated employee training, validation, and change control documentation.-Developed Standard Operating Procedures (SOPs), Master Batch Records, and associated training modules and documentation.-Led product investigations to identify root cause and develop effective corrective and preventative actions. -Managed regulatory safety program requirements for EPA, Oregon DEQ, OSHA, and DOT programs including the Hazardous Waste Large Quantity Generator program, Hazardous Material Shipping program, Emergency Response Action Plan, and all associated employee safety training.

-Performed process development, optimization, and transfer of polymer based spray-dried pharmaceutical products to client designated sites.-Developed manufacturing specifications for new products.-Served as technical liaison for GMP manufacturing at external contract manufacturing vendors.-Participated as lead process engineer for the design and installation of a $20M cGMP facility (BRPPD). Supervised all project management aspects for installation of a $4M pilot-scale pharmaceutical solvent rated spray dryer.