Privately own Consulting firm helping improve and develop quality systems for pharmaceutical, health/beauty, and consumer goods.

Developing and implementing quality assurance and quality control processes and procedures.Conducting research and analysis to identify the strengths and weaknesses of current quality practices.Reviewing policies and regulations to ensure compliance and alignment with industry best practicesCoordinating with other staff to gather and analyze data, reporting on quality performance and, improvement opportunities.Testing and inspecting products and services and identifying and resolving defects and issues.Designing and executing test-automation systems for validation and verification.Providing training and guidance to staff on quality-related topics.Evaluating and recommending quality tools and techniques.

Providing quality and operational systems supportWriting Annual Product Review (APR)Providing consulting services for investigationsProviding input for effective CAPAaProviding support for system and facility upgrades and enhancementsNew Equipment selection, IQ/OQ/PQ

Took charge of converting the facility from a CBD Research and Development facility to full Commercialization CBD facility.Directly performed gap analysis of compliance and operational aspects of the facility; written, approved, trained, and implemented numerous training and process related documentation.Responsible for the improvement of efficiency of business, maintaining control of diverse business operations, and securing the functionality of business to drive extensive and sustainable growth.Responsibilities of the role include: • Lead the operations and management of conversion to a large-scale ethanol extraction and manufacturing facility• Design and implement business strategies, plans and procedures• Set comprehensive goals for performance and growth• Establish policies that promote company culture and vision• Oversee daily operations of the company during transition period• Ensure regulatory compliance, including safety, environmental and document control requirements• General HR functions, including conflict resolution, staffing, on-boarding and training• Lead employees to encourage maximum performance and dedication• Ensure equipment reliability throughout production process, scheduling maintenance to ensure minimal down time• Evaluate performance by analyzing and interpreting data and metrics• Written and submit reports to Executive Management in all matters of importance• Lead company expansion initiative• Manage relationships with partners/vendors

• Direct all aspects of 50,000sq ft facility and 40,000sq ft secondary warehouse sites including maintenance, quality, and operations• Direct the manufacturing, packaging, and distribution of both proprietary and CMO pipeline, including development of new ANDA and R&D activities for manufacturing and packaging totaling 44 products with multiple skews totaling 32 mil sales for 2019• Manage site P&L, operational budget, including inventory, direct labor, overhead, operations, and quality• Implement a continuous improvement environment focusing on a “right-first-time” approach and reduction of redundancies• Decrease operational COGs 15% year over year through efficient management of quality, cost control methods and improved utilization of resources• Determine site staffing requirements; directly involved with the interviewing and hiring process for site personnel• Developed site leadership team for all internal, external, customer, and FDA audits• Direct responsibility for External Customer interaction with accountability for manufacturing, packaging, quality, and compliance• Fostered principles of QbD and QMS throughout entire facility through improved training programs, communication, and metrics resulting in the improvement of 60% throughput• Conducted site evaluation of manufacturing/packaging equipment and site utilities and implemented process for upgrades to same• Selected and onboarded state of the art processing equipment• Ensure timely, accurate production planning process is maintained, including sourcing and purchasing; coordinate repair and equipment and site maintenance• Establish, implement, and monitored departmental goals, objectives and procedures, conferring with leadership member(s), management team, and staff as necessary• Fostered a “Safety First” culture through the implementation and enforcement the safety program• Experience writing, developing, and approving SOPs, IQ/OQ/PQ protocols, and other regulatory documentation

• Direct responsibility for defining business processes and solutions for implementation of quality improvements and best practices for GMP compliance resulting in the reduction of quality and personnel related issues by 70% within 18 month period• Decrease in operation incident rate and achieved 95% RFT, reduction of quality and personnel related issues by 70% within 18 month period, achieved and sustained 0% overdue incident and CAPA levels. Increased outputs for Dr Reddy products and, met and exceeded expectations as a CMO• Direct all aspects of Manufacturing and Packaging operation of 180 employees contributing to the growth in generic sales• Direct onsite, global, and external customer interaction with accountability for manufacturing, packaging, quality, and compliance• Continuous interaction with corporate and site validation, engineering, and maintenance groups for site upgrades, improvements, expansions, new equipment, and site transfer activities • Knowledge and direct involvement with United States – FDA and internal and external audit groups.• Direct Manufacturing and Packaging operation of 150 employees contributing to 27% growth in generic sales during FY14• Direct onsite operations and provide leadership to meet external customer needs, interaction and accountability for manufacturing, packaging, quality, and compliance groups

• Performed US and Global site audits for cGMP and compliance readiness and conducted remediation programs• Knowledge and direct involvement with United States - FDA, Canadian – HPB/Health Canada, and European - EMA agency requirements• Collaboration and interaction with manufacturing, quality, and compliance groups for all Teva, Pliva, and Barr facilities in United States, Poland, Croatia, and Canada• Responsible for Quality investigation, compliance, and FDA responses; developed and monitored CAPA administration, compliance and remediation teams• Direct project responsibility for defining business processes and solutions for selection and implementation of Oracle based ERP system for multiple US based facilities• Developed and managed continuous improvement projects for manufacturing and quality operations for US and International divisions• Responsible for the control of operational budgets, forecasting and production capacity plans, and constraint evaluation for manufacturing operations• Continual over site and direction to all facets of organization, including Research and Development, Validation, Quality, Packaging, Manufacturing, and Distribution to ensure compliance with all FDA regulations, safety, and quality• Responsible for directing seven area supervisors and ninety-eight manufacturing technicians across multiple shifts; Responsible for scheduling manufacturing resources including equipment, labor, materials, and maintaining budgetary requirements• Provided GMP training to US based manufacturing facilities• Implemented best practices for all Barr and Pliva manufacturing facilities• Develop and maintain manufacturing cGMPs and FDA compliance training, tracking, and compile manufacturing data, prepare and maintain facility efficiency and production reports for distribution to the Vice President of Operations

Owner/President Licensed, certified, master designer and installer of commercial, residential irrigation system, electrical, plumbing, and water conservation systemsCreated and Incorporated irrigation and night lighting business into northeast competitive businessDesigned, estimated, marketed, and serviced the installations of irrigation and night/accent lighting systems for industrial, commercial, and residential sites. Managed all aspects of field and office operations

Engineering / Maintenance System Development• Performed capital equipment selection and installation/operational qualifications• Established and maintained preventive maintenance tracking system for three interstate manufacturing facilities• Directed and trained maintenance personnel in proper procedures to perform facility and equipment preventive maintenance and calibration functions• Conducted facility safety and cGMP audits and employee training sessions

Various positions of increasing responsibility, from operator, supervisor, to final role as Pharmaceutical Engineering Validation Coordinator.• Assisted in establishing and maintaining divisional personal computer network including computer hardware and software selection, installation and system maintenance• Developed early stage computer assisted pharmaceutical process system• Performed retrospective and concurrent product testing and statistical data analysis to compile Validation Protocols for non-sterile finished products• Investigated manufacturing procedures, processes, equipment, raw material, and in-process controls to ensure compliance with GMP and FDA regulations• Directed and supervised 28-44 employees including 3 supervisors, scheduled complete equipment maintenance, over-haul, set-up operations for entire production operations