Ed Garcia- Resume Full

Edward Garcia 5930 83Place847-309-7762 cell Kenosha, WI [email protected]

Quality Assurance/Training SpecialistProven Quality Assurance/Training Specialist with a vast array of experience in multiple industries including Pharmacy, Pharmaceutical/Biotech, Property Management and Food Industry to name a few. I have a proven track record of reducing costs and seeking out efficiencies in every job process, reducing cost and increasing compliance. I offer a mentality of ownership, leadership, mentorship and loyalty, with the ability to adapt, educate and motivate team members in addition to providing resolution to complex and unique problems. Below I cover many of the details with which I can help you reach your company goals, enhance company culture and assist in achieving and enhancing compliance for your company.

Accomplishments: Supervision – managed a staff of up to 230 employees in both retail, military and restaurant environments Author –wrote multiple internal Quality System documents and training presentations Quality System - managed the doc center and change control process for Pharmacy Solutions Quality System Training/Facilitation – successfully managed the learning management system including development and

review of curriculum, logistical coordination of training events globally, record management, vendor contract and SOW negotiation, creation of training presentations and facilitation of classes.

Technical – successfully manage SharePoint and Isotrain as SME administrator including system audit and reporting for Pharmacy Solutions

Quality –maintained compliance under dept., corp., regulatory, safety, DEA, DOT, Pharmacy Board and FDA guidelines, including ACHC Accreditation for aspects I was involved with. I furthermore have Cold Chain Management, CAPA and Complaint handling, auditing and controlled drug administration experience, including import clearance and export compliance.

Logistics – managed logistics project for solvent recycling between Puerto Rico and Chicago Safety Kleen. Streamlined the logistics process resulting in significant efficiencies and savings for 2004.

Planning - managed and assisted with the planning of API inventory supply for HPD Planning and GPO Biologics commodity replenishment

Skills: Change Management Project Management Auditing Continuous Improvement Problem Solving/Resolution Microsoft Office Suite

Outlook Quality Document Management System Class A Lean Six Sigma tools Second language: Spanish Facility and Employee Safety

ABBVIE Biotechnologies April 2016-January 2017 Division: Pharmacy SolutionsPosition: Pharmacy Licensing and Compliance AnalystAccomplishments include:

Maintained and tracked all pharmacy licenses including renewal application submission for all fifty states and territories of the US and ensuring pharmacy compliance against all state laws

Maintained and tracked all controlled drug waivers and reporting for the pharmacy for all fifty states Monitored all pharmacist, nurse and pharmacy technician licenses and certifications for compliance with

applicable state requirements for over three hundred employees in a call center environment Monitored all door security clearance and granted or disabled access as required by the business Monitored all alarm reports and review with the Pharmacist in Charge to assure compliance with state law Organized and restructured all electronic and hard copy files for ease of use and location to allow the pharmacy

to be inspection ready at all times

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ABBVIE BiotechnologiesPosition: QA Training Specialist Nov 11, 2013 – Present Division: Pharmacy SolutionsAccomplishments include:

Managed the Pharmacy Doc Center and redevelopment and design for SharePoint Developed and implemented trainer qualification, training review and change control and training effectiveness Developed metric reporting on Change Requests, Doc Center and Continuous Improvement activity Introduced curriculum development and curriculum deployment in Isotrain Trained and developed SMEs, Approvers and QA reviewers with all aspects of our internal change control

processes and systems in a call center environment of over three hundred employeesPosition: Quality Assurance Training Coordinator Dec 10, 2012 – Present Division: Pharmacy SolutionsAccomplishments include:

Implemented annual doc review, reformatted and streamlined all operations Quality System documentation Successfully Lead miscellaneous projects and implemented improvements as necessitated by the Pharmacy Lead Continuous Improvement efforts involving the PS Sharepoint Database including training and support Performed data analysis and metric reporting on Change Request and Doc Center activity for the Pharmacy Implemented Taken Past due training investigations and exception reporting for the Pharmacy training program

ABBOTT LABORATORIES Position: Quality and Regulatory Training Coordinator June 2010 – Dec 7, 2012 Division: ADM/AQRAccomplishments include:

Coordinated scheduling, ordered duplication of training materials and handled logistics for numerous domestic and international classes

Created and updated classes in the Abbott Training Registration System (ATRS) including yearly training forecast and schedule update

Redlined and updated departmental procedures as necessary to align with Abbott’s Quality System Conducted metric reporting for Corrective Action Preventive Action (CAPA) and Complaint training, monthly help desk

reporting and financial reporting for classes conducted including coordination of financial chargeback Coordinated and assisted in the Production of WEBEX training

Position: Distribution Quality Assurance May 2008 – June 2010 Division: GPOAccomplishments include:

Performed product holds, package withdrawal, and rework investigations using Order Processing System (OPS) Conducted CAPA investigations in Global Quality Management System (GQMS) as an Initiator/Evaluator,

Investigator and Resolution Planner Conducted product complaint investigations as in Initiator/Evaluator and Investigator using the Product

Complaint Analysis (PCA) website Completed release of FDA and United States Department of Agriculture (USDA) importation issues Worked with Abbott Package Engineering with the study of transportation routes affecting Cold Chain products

and packaging qualifications Monitored temperatures for compliance and tracked temperature monitoring devices and assured calibration

testing was accurate and on timePosition: Training Coordinator June 2004 – May 2008 Division: GPOAccomplishments include:

Managed training compliance for 28 different departments under Global Supply using Active Learner and Isotrain

Created, implemented, maintained and updated job functional curricula Created and facilitated instructor led training for specialized job requirements Interacted with all levels of management for training compliance and metric reporting Facilitated Continuous Improvement training for Global Supply Chain employees Conducted system migration from Active Learner AHD to Active Learner SPD and then consolidate the data into

Isotrain2


Position: Reimbursement Specialist/Materials Management January 2003 – June 2004 Division: SPDAccomplishments include:

Supported GPO Marketing, Research and Development scientists as well as Manufacturing and Warehouse operations Conducted order processing, non-product billings and expedited priority International and Domestic orders Managed inventory supply levels and request sampling for testing of incoming products for manufacturing use Created and implemented shipping export documentation, commercial invoices, manifests and Hazardous

Material Declarations Provided Interdivisional customer service to Hospira, Pharmaceutical Products Division, Abbott International,

New Orleans Louisiana Distribution and Puerto Rico operations Controlled the logistical coordination of solvent transportation from Abbott Chemical Plant and Chicago Recycling

Center, including review and approval of payment for transportation services Became certified for DOT Hazardous Material Classification and labeling for Road, Air and Ocean shipments

Position: Senior Drug Dispenser March 2001 – January 2003 Division: SPDAccomplishments include:

Controlled pharmaceutical bulk raw material dispensing and commodity dispensing for Biological manufacturing Performed training of warehouse personnel for certification of gas and electric forklift operation for Lake County Ops Monitored and maintain temperature recording equipment and acted as safety representative and back up group

leader for the department Safely operated gas and electric forklifts and cube trucks for delivery and transportation of materials to manufacturing

Position: Chemical Dispensing Technician February 1999 – March 2001 Division: ADDAccomplishments include:

Recorded and dispensed, received and controlled inventory through inventory system management Coordinated delivery receipts and returns, issued and allocated chemicals to work orders and performed

temperature monitoring Conducted On The Job training and performed duties as a back-up Training Coordinator for the department Updated operating procedures as needed Safely operated and trained personnel on various types of material handling equipment including highbay and

order picking forkliftsPosition: Fill /Label Aseptic Machine Operator June 1997-February 1999 Division: ADDAccomplishments include:

Operated multiple diagnostic solution filling machines for different size vials, including changeover and set-up of equipment and line clearances

Setup of linear and peristaltic pumps including in line filtration systems and gravimetrical scales Operated filling from various solutions containment including large tank and roller carriage for magnetic particle filling Set up and dispensed human and animal sourced materials including hazardous and radioactive solutions

Significant Accomplishments: Corrected a billing error resulting in a vendor refund for tanker washes in the logistics billing cycle Coordinated Flex training for the Chicago Distribution Center to help prevent personal injury and optimize

departmental cost savings due to time off related personal injury Made recommendation to Abbott to open the recycling to all Abbott personnel who did not have recycling in

their communities. Abbott reviewed and implemented various sites for employee drop off of recyclable materials.

Streamlined logistics processes with FEDEX Office duplication ordering for the department by implementing an online ordering system and assisting in the customization of the FEDEX On Line Doc Store, which will result in a cost savings of approximately $12,000 annually in shipping charges and $3000 annually in streamlined printing processes for training materials

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Class A-Coordinated the training development for Lake County’s Global Pharmaceutical Operations Global Logistics Class A initiative

Streamlined training system effectiveness by implementing Curricula processes in the Learning Management System for Pharmacy Solutions, creating efficiencies with Onboarding and Offboarding of employees, and accuracy of training curriculum for specific job functions.

Managed the logistical coordination of training events globally, record management, vendor contract and SOW negotiation, creation of training presentations and facilitation of classes creating efficiencies of approximately ten percent.

Education: Currently enrolled in College of Lake County, Business Management

Volunteerism: Usher for Great Lakes Church Security for Child Care area of Immanuel Baptist ChurchHobbies: Biking, fishing, gardening, word-working, painting and auto restoration

Please visit my page for my personal recommendations:

https://www.linkedin.com/pub/edward-garcia/36/110/b76

References available upon request

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Ed Garcia- Resume Full

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