Tony Adrian Email & Phone Number

Indianapolis, Indiana, Us

Implement business process automation using PowerApps, Access, and other technologies depending on customer requirementsCreate business applications and relational databases in MS Access, SQL Server, and PowerApps to support uploads from SAP and manual entries from QA and business area teamDesign, create, implement and maintain MS Access databases to manage QA team packaging order Review schedules, collect batch issues, and provide reports, forecasts, and summaries of area performanceOversee project management applications in PowerApps to collect ideas, and to provide balance sheetsCollaborate with area managers to create a PowerApps application to condense 600K records from SAP to reduce the time needed by an estimated 700 hours per yearDevelop and implement systems to support continuous improvement projects, yielding the following savings:Reduced time to review packaging batch records by 10-50%Reduced time to review labelling packages by 50%Reduced time to upload data from SAP from six hours to 10 minutes

Indianapolis, Indiana, Us

Ensure quality production requirements are met to prevent defects in services and products Advice on maintenance procedures and mandatory regulations and guidelinesProvide technical support to teams performing vulnerability tests to prevent the recurrence of operational issuesReview study batch records related to packaged clinical trial drug products Perform person in plant activities at CMO sites to ensure compliance to Lilly and cGMP requirementsAnalyze and counsel CMOS on the complaint and problem report investigationsOversee improvements related to SOP and training and CMO problem report investigationsDevelop and implement relational database applications to connect US and European Quality groups and operational metrics collection using MS Access and SQL ServerCollaborate with outsourcing group to ensure CMO compliance to current quality and business agreements

Indianapolis, In, Us

Managed quality management system to represent the company at all certification and customer quality auditsDeveloped and implemented policies, SOPs, training curriculum, and processes to maintain registration and complianceOversaw implementation of validation master plan, equipment, and process validationsTrained and coach employees on quality and operational excellence and best practicesAnalyzed problem reports, complaints, deviations, and associated CAPAsManaged all quality and training documents and document management systemLeveraged assistance in efforts to integrate QMS with ERP systemDesigned a duty-based training curriculum for all employeesHandled management review meetings with executive management

Advised companies and individuals to identify requirements, plan, and processes to achieve personal and corporate goalsAnalyzed current level of performance and made recommendations on process improvementsTrained small business owners on basic office methods and softwareCoached individuals on job and career strategies, networking, and job searches;Trained small business owners on job costing strategies and estimate to actual comparisons using MS Excel, QuickbooksProvided other support as necessary for small business owners

Norwalk, Connecticut, Us

Managed global costing model and budget for instructor-led classesDesigned and implemented a business operations process, including CAPA and PDCA processesOversaw annual planning for classes and facilitiesCollaborated with customers to gather requirements to design and develop service delivery solutionsManaged financial control and reporting for services deliveryOrganized all activities for staffing, resource planning, and utilizationDeveloped statements of work for a variety of learning and development projectsAssisted in collecting, managing, analyzing, and reporting on learning and development metrics

Indianapolis, Indiana, Us

Responsible for managing outsourced service providers, developing and negotiating contracts with external vendors, procurement of learning and development related services and materials, leading process improvement projects, and managing the day to day activities and relationships involving external service providers and internal Lilly customers.• Manage $3MM + training contracts, budget, and facilities;• Manage external service provider consisting of 40+ employees providing services for US and OUS customers;• Created proposal and participated in RFP process for a new service delivery model which will save over $20MM per year;• Manage business and collect and present data regarding customer satisfaction, quality performance, customer satisfaction surveys, and performance to budget plan;• Lead training delivery process improvement projects as a Six Sigma Green Belt;• Implemented an activity based costing system to control overall training costs and recovery;• Negotiated master service agreements with external learning and development service providers;• Initiated and executed continuous improvements to the training facilities, service offerings, and ease of doing business with the training support services and facility.

Indianapolis, Indiana, Us

Responsible for providing quality support for a pharmaceutical manufacturing/filling plant and global distribution warehouse. • Part of a new engineering team to remediate sterile parenteral filling and respond to FDA 483 warning letter and observations;• Approved qualification documents related to facilities, equipment and utilities in a manufacturing and distribution environment: cGMPs, IQ/OQ/PQ, commissioning, FMEA, functional testing, receipt verification, RCA, and change control documents; • Investigate and approve deviations, CAPAs, and change controls using quality processes (Trackwise);• Led efforts to improve change control processes, procedures, and training;• Performed internal audits of facilities and equipment to ensure audit readiness;• Led efforts to implement a risk based approach to commissioning and qualification so that the qualification process correctly identifies which attributes or characteristics should be subjected to commissioning versus IQ and OQ testing and approval; • Developed and facilitated qualification and change control training sessions for engineers and plant personnel.

Columbus, Indiana, Us

Responsible for providing purchasing support for a variety of components necessary for assembling diesel and natural gas engines for a global customer base. • Was responsible for supporting team transition to a new, global ERP system;• Led quality and cost improvement projects aimed at reducing the total cost of ownership for a variety of diesel engine components;• Led quality and business audits of new and existing suppliers prior to awarding new contracts;• Negotiated component costs with suppliers and led cost reduction projects that saved over $125,000 per year;• Facilitated global diversity training classes for procurement, engineering, and production staff;• Successfully led efforts to improve component suitability for a fuel system seal that also reduced annual costs by over $100,000 by selecting a different manufacturing method available by a new supplier;• Led efforts to streamline engineering change management process so that notices to and from the ERP system could be updated within 24 hours as opposed to two weeks.

Indianapolis, In, Us

Responsible for leading efforts to implement a quality system and upgrade business systems to an ERP system. Provided contract assembly and packaging support for the automotive, animal health, packaging, safety products, and other industries.• Implemented a quality system modeled after cGMPs, ISO 9002, and QS 9000;• Developed business processes and maps necessary to RFP various ERP systems;• Led efforts to identify and select candidates for RFQ and selection of ERP system;• Lead implementation of ERP and lean processes in administration and manufacturing areas;• Member of management start up team for new 300,000 sq. ft. assembly and distribution facility;• Developed and implemented quality processes and facility material flow processes for new facility providing contract assembly and packaging services;• Managed quality department staff.

Us

Responsible for all quality and compliance activities related to the Indianapolis division of Keller Crescent Co. which was a printing and assembly plant dedicated to producing products in a cGMP environment and providing products for customers in the pharmaceutical industry. • Member of management start up team for a new 200,000 sq. ft. facility dedicated to printing products outsourced from Eli Lilly and Company and other pharma companies; • Member of Manufacturing Requirements Document team that maintained quality and delivery agreements between Keller Crescent and the major customers;• Responsible for vendor selection, development, and qualification;• Main point of contact for customer inquiries and external quality audits;• Developed and implemented a quality system compliant to cGMPs, ISO 9002, and QS 9000;• Created and facilitated classes teaching quality methods and theories including PDCA, SPC, FMEA, and others;• Developed new and improved printing processes and technologies necessary to meet changing customer needs;• Managed quality department staff and self directed work teams in the manufacturing areas.

Irvine, California, Us

Responsible for quality activities related to the Mazda North America division providing automotive components for the Automotive Alliance assembly plant in Flat Rock, MI and service parts for Mazda and Ford vehicles. • Developed annual quality plan using various quality tools (SPC, FMEA, etc.) aimed at improving product quality, reducing defects, and improving quality department performance;• Led efforts to develop global supplier base per the quality expectations of Mazda North America;• Led and approved first article inspection process;• Led and participated in audits with Japanese managers;• Represented quality department at senior management meetings consisting of Japanese senior executives and managers;• Provided training to quality engineers on metrology and inspection processes and methods;• Created and implemented databases to better manage service part receiving and inspection processes.

Responsible for developing a Q101 compliant quality system including material traceability system, gauge and fixture calibration and traceability, production routers, and process for quality checks at critical points during manufacturing process. Represented company during customer quality audits and elevated customer quality ratings from a D to an A in three months. Managed customer complaint process and led teams investigating quality issues and developing 8D reports. Responsible for SPC process and training employees on SPC processes and metrology.

Built tools, dies, and fixtures using a variety of tool room equipment (vertical mills, grinders, lathes, welders, forming equipment, etc.). Created drawings, engineered manufacturing processes, and developed production routers. Provided QC engineering support and QC inspection of precision welded sheet metal assemblies and precision machined components for a variety of aerospace customers including GE, P&W, Allison Gas Turbine, and Rolls Royce. Worked with president developing unique and cutting edge manufacturing methods aimed at improving quality and reducing variability, and reducing set up times.

Master Of Business Administration (Mba), Business And Finance

Bachelor Of Applied Science (B.A.Sc.), Mechanical Engineering/Mechanical Technology/Technician

Associate Of Science (A.S.), Mechanical Engineering/Mechanical Technology/Technician

Education record