• Authorized Principal Consultant for NSF International• Senior Laboratory Regulatory Consultant for FDA Compliance Group.• Assist clients in response to FDA’s issuance of 483’s and Warning Letters• Design Quality Management Systems• Design HACCP programs• Design Sanitation Programs• Design Shelf Life Stability Studies• Conduct Supplier Qualification Audits• Conduct Laboratory Qualification Audits• Label Regulatory Review• Conduct ISO Gap… Show more • Authorized Principal Consultant for NSF International• Senior Laboratory Regulatory Consultant for FDA Compliance Group.• Assist clients in response to FDA’s issuance of 483’s and Warning Letters• Design Quality Management Systems• Design HACCP programs• Design Sanitation Programs• Design Shelf Life Stability Studies• Conduct Supplier Qualification Audits• Conduct Laboratory Qualification Audits• Label Regulatory Review• Conduct ISO Gap Analysis• Conduct compliance Gap Analysis• Conduct monitoring and initial audits.• Manage enforcement issues stemming from certification audits• Conduct special visits to investigate product failures and verify the implementation of corrective actions taken• Develop cost effective work plans for obtaining certifications• Establish and maintain effective communication with program representatives and project managers as it relates to assigned clients Show less

• Development and implementation of the appropriate risk management framework for the investment department and portfolio. • Conduct periodic reviews and updates of market and credit risk model parameters. • Locate and research potential property investments• Research property owner, history, financials; determine correct contact person• Acquire and analyze property offering memoranda• Collaborate with team to build and manage database of investment targets• Verify… Show more • Development and implementation of the appropriate risk management framework for the investment department and portfolio. • Conduct periodic reviews and updates of market and credit risk model parameters. • Locate and research potential property investments• Research property owner, history, financials; determine correct contact person• Acquire and analyze property offering memoranda• Collaborate with team to build and manage database of investment targets• Verify, change or create underwriting assumptions on potential real estate investments• Interface with the local brokerage community to farm deals for acquisition and create business contacts• Complete contracting paperwork and procure all signatures• Review and evaluate quality of titles• Monitor and evaluate financial operating results on a monthly basis• Research and calculate market rents, gross yields, net cap rates, optimal purchase price, vacancy rates, location nuances, favorability for appreciation, and market trends• Research real estate markets for potential investments• Analyze existing investments• Monitor investments to ensure completion on-time and on-budget• Monitor and evaluate financial and operating results on a daily basis• Track economic and performance indicators within real estate market• Establishes rental rate by surveying local rental rates; calculating overhead costs, depreciation, taxes, and profit goals.• Attracts tenants by advertising vacancies; obtaining referrals from current tenants; explaining advantages of location and services; showing units.• Contracts with tenants by negotiating leases; collecting security deposit.• Accomplishes financial objectives by collecting rents; paying bills; forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective action.• Enforces occupancy policies and procedures by confronting violators. Show less

Scenic tours of Carquinez Strait and Napa Valley. boat chartering, fishing trips, and overnight accommodations.

• Responsible for quality leadership of all manufacturing facilities and distribution centers, both domestic and international• Ensure quality standards are met to support the business and provide alignment across facilities, domestic and international• Provide quality leadership across the organization and to other business units• Continuously improving and raising the standards across the organization to meet regulatory and customer requirements• Host regulatory and… Show more • Responsible for quality leadership of all manufacturing facilities and distribution centers, both domestic and international• Ensure quality standards are met to support the business and provide alignment across facilities, domestic and international• Provide quality leadership across the organization and to other business units• Continuously improving and raising the standards across the organization to meet regulatory and customer requirements• Host regulatory and third-party audits of facilities• Allocate resources to support manufacturing, development, and commercialization of products• Instituted formal operating procedures and enforced adherence to policies and regulations that impacted the bottom line• Leveraged professional networks and industry knowledge to strengthen client relationships• Directed design and execution of business transformation initiatives to drive performance, profit optimization and growth opportunities.• Oversaw operations and provided corrective feedback to achieve daily and long-term goals• Drafted and distributed reports to assist board members with critical business decisions• Performed continuous evaluations of the business facility, teams, and policies to keep operations efficient and consistent• Established departmental performance goals and provided feedback for underperforming areas. Show less

• Provide scientific guidance for testing activities related to process development, validation, deviation investigations, compatibility assessments, etc.• Ensure appropriate analytical technologies are implemented for quality testing, and demonstrate first-hand knowledge of physico-chemical, biological and microbiological methods commonly used• Maintain and enhance validation of analytical methods, specification development, data trending (out of trend, out of specification… Show more • Provide scientific guidance for testing activities related to process development, validation, deviation investigations, compatibility assessments, etc.• Ensure appropriate analytical technologies are implemented for quality testing, and demonstrate first-hand knowledge of physico-chemical, biological and microbiological methods commonly used• Maintain and enhance validation of analytical methods, specification development, data trending (out of trend, out of specification investigations, etc.), expiration dating, and reference and reagent qualification.• Support continuous improvement initiatives to enhance compliance, efficiency and effectiveness of quality systems.• Develop long-term strategies for automation and use of electronic data systems.• Represent the company at regulatory inspections and audits, and defend QC results, laboratory practices and documentation systems.• Manage a budget, set achievable goals, and lead complex projects to completion.• Build group cohesiveness and maintain and strengthen relationships with Quality, Manufacturing, Compliance, Process Development, Regulatory Affairs and others.• Ensure that all procedures, specifications and other GxP documentation which impacts on GMP, GLP and GPVP activities performed by or on behalf of Pro-Form Laboratories are sound from both a scientific and compliance perspective.• Conduct audits to verify adherence to procedures and requirements for both internal and external systems and processes, where applicable• Manage the supplier qualification program, as it applies to GMP, GLP and GPVP activities performed on behalf of Pro-Form Laboratories• Provide ongoing training for the organization in compliance with current regulatory standards for quality• Conduct internal and external cGMP audits; write audit reports• Oversee maintenance of deviations investigations and corrective actions database• Write investigation reports for OOS and track effectiveness of corrective actions Show less

• Process improvements utilizing Kaizen/Lean/Toyota Production System methods• Oversee Compliance key performance indicators and other department metrics accountability and reporting• Facilitate effective project management for all Compliance initiatives, which includes defining scope of work, assigning appropriate resources and prioritizing and tracking project work.• Manage company budget and work closely with CFO to align financial priorities.• Assist in the coordination of… Show more • Process improvements utilizing Kaizen/Lean/Toyota Production System methods• Oversee Compliance key performance indicators and other department metrics accountability and reporting• Facilitate effective project management for all Compliance initiatives, which includes defining scope of work, assigning appropriate resources and prioritizing and tracking project work.• Manage company budget and work closely with CFO to align financial priorities.• Assist in the coordination of regulatory responses to insure accurate and timely in the company's communications to regulatory agencies.• Develop strong working knowledge of AA's processing and technology environment to facilitate effective and efficient project management.• Maintain a thorough understanding of all relevant Risk Management priorities and Compliance laws and regulations• Represent Compliance as needed on various firm wide efforts and initiatives.• Review and Approve product labels and documentation for adherence to regulatory requirements including: claims, supplement facts panel and ingredient statement• Train all laboratory personnel in sample handling, analytical procedures, and instrumentation• Manage laboratory expansion and market capture strategy
• Develop and implement: SOPs, SSOPs• Help design and implement a sustainability platform • New Product Development• Research and Development projects relating to hops and beer analysis• Database development for laboratory testing• Brewing, fermentation and dispensing equipment engineering Show less

• Plan, organize, and manage the day to day compliance activities• Participates in various committees, audits, and examinations.• Advises the Board of Directors, Senior Management and personnel of emerging compliance issues and consulted and guided in the establishment of controls to mitigate risks.• Coordinated risk assessment and monitoring of subsidiary compliance management programs.• Ensures department activities run smoothly and efficiently by providing leadership… Show more • Plan, organize, and manage the day to day compliance activities• Participates in various committees, audits, and examinations.• Advises the Board of Directors, Senior Management and personnel of emerging compliance issues and consulted and guided in the establishment of controls to mitigate risks.• Coordinated risk assessment and monitoring of subsidiary compliance management programs.• Ensures department activities run smoothly and efficiently by providing leadership, training, and supervision to compliance department personnel.• Demonstrate knowledge of applicable laws and regulations. Inform key personnel about changes in laws and regulations and their implications for policies and procedures.• Proactively review and assess new and existing products, capabilities, and opportunities from a compliance risk perspective• Process improvements utilizing Kaizen/Lean/Toyota Production System methods• Create and implement organizational polices, standards and procedures to comply with applicable regulations• Enforce standards through disciplinary policies to ensure achievement and maintaining compliance• Support each department through application of corrective and preventative actions, training, continuous improvement process• Perform internal audits of Quality Systems (process/facility inspections, equipment and record review and training records) to ensure compliance with current procedures.• Responsible for leading internal audits for each location from planning, execution, documentation, follow-up, gap closures, implementation of corrective actions and training.• Act as an internal liaison with company’s external auditors.• Strengthen Supplier Approval Program by performing risk assessment of suppliers and performing audits as necessary.• Responsible for manufacturing, distributing and consistently maintaining safe and quality food by following good manufacturing practices, allergen controls, food defense, HACCP and SQF requirements Show less

• Develop and Commission Pilot and Manufacturing Scale Processes • Design, develop, and commercialize processes for new products and product optimizations. • Conduct hands on bench and pilot scale tests• Design processes to ensure products are reproducible and robust enough to meet consumer expectations, quality and cost requirements, and supply of raw materials, with consideration to the impact on plant operations• Travel as needed to conduct product/process commissioning and… Show more • Develop and Commission Pilot and Manufacturing Scale Processes • Design, develop, and commercialize processes for new products and product optimizations. • Conduct hands on bench and pilot scale tests• Design processes to ensure products are reproducible and robust enough to meet consumer expectations, quality and cost requirements, and supply of raw materials, with consideration to the impact on plant operations• Travel as needed to conduct product/process commissioning and to provide manufacturing support for existing processes. • Serve as technical leader on cross functional project teams• Effectively manage technical timelines and multiple projects with competing deadlines• Align with Operations to develop best practices and standards that are consistent across the manufacturing facilities.• Demonstrate creativity, foresight, and mature judgment in anticipating and solving problems that arise from processing food and/or beverage products• Remain abreast of new processing technology and present concepts for application• Initiate and direct research and product development programs for effective introduction of new products and processes to fulfill the strategic plan.• Identify, develop, and pursue opportunities to improve strategy, execution, and organization of R&D.• Select, develop, organize, motivate, and coordinate staff to effectively fulfill their functions. Manage the HR pipeline, building the necessary skills to execute the R&D plan and provide for effective leadership succession.• Ensure compliance with quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.• Ensure compliance with all local, state, federal, and safety regulations, policies, and procedures. Show less

• Examination of rates and forces that affect genetic transfer between organisms• Develop and maintain genetically modified cell lines • Supervise and teach new techs• Weekly presentations and quarterly reports stating current findings and future plans• Interact with business and technical people, adjusting language and style, but able to lead both in a conversation around requirements gathering, problem determination and resolution, risk analysis, impact sessions… Show more • Examination of rates and forces that affect genetic transfer between organisms• Develop and maintain genetically modified cell lines • Supervise and teach new techs• Weekly presentations and quarterly reports stating current findings and future plans• Interact with business and technical people, adjusting language and style, but able to lead both in a conversation around requirements gathering, problem determination and resolution, risk analysis, impact sessions, etc.• Develop clear and comprehensive test cases, test plans and test strategies• Maintain and execute a suite of manual test cases, building to a level of understanding such that a summary of test results per area can be provided; to maintain the suite and adjust to need modifications (changing and retiring test cases)• Ability to assess work load and determine work item priority, which subset of test cases are necessary to run, based on priority and risk, and how to work independently, when necessary• Ability to effectively use test case management tools, bug tracking tools, understand the concept of uniformity and consistency, yet always maintaining an attitude of continuous improvement Show less