Ed Garcia

Ed Garcia Email and Phone Number

Quality and Continuous Improvement Manager @ Kem Krest
Kenosha, WI, US
Ed Garcia's Location
Kenosha, Wisconsin, United States, United States
Ed Garcia's Contact Details
About Ed Garcia

Experienced Quality, Training, Distribution and Production Manager well versed in the Biotech, Supply Chain, Medical Device, Pharma and Food industries, seeking new career opportunities. Focused in CAPA, Complaints, Auditing, Training, HR, Continuous Improvement and Document Control. Highly skilled in Inventory Management, Cold Chain, Logistics, Import/Export activities, Safety and Warehousing.

Ed Garcia's Current Company Details
Kem Krest

Kem Krest

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Quality and Continuous Improvement Manager
Kenosha, WI, US
Website:
kemkrest.com
Employees:
353
Ed Garcia Work Experience Details
  • Kem Krest
    Kem Krest
    Kenosha, Wi, Us
  • Kem Krest
    Quality And Continuous Improvement Manager
    Kem Krest Feb 2024 - Present
    Elkhart, Indiana, Us
  • Ariensco
    Distribution Center Lead
    Ariensco Mar 2023 - Feb 2024
    Brillion, Wi, Us
  • Jabil Healthcare
    Quality System Supervisor
    Jabil Healthcare Oct 2021 - May 2022
    St Petersburg, Florida, Us
    • Monitored/evaluated level of involvement of QA Department activities and the positive effects on efficiencies and continuous improvement created across the organization by sharing knowledge across the organization in compliance with CFR820, CFR210 and CFR211.• Managed all Quality Department operational metrics to drive continuous improvement with the ability to compare and trend data collected, driving departmental growth and improvement.• Evaluated effectiveness of the Quality Management System at Jabil and improved as necessary, including the creation of automated forms for minimizing documentation and human errors, increasing efficiency and accuracy of data entry for the manufacturing Device History Records in compliance with GDP.• Led the department to adhere to all safety and health rules and regulations associated with the company and made several integral suggestions which were implemented at the site in compliance with OSHA standards. • Updated and created numerous Work Instructions and Procedures to streamline practices after mapping the processes with the team and submitting the process improvements to the Lean Project Manager, with a total accumulated time savings of 15% in process streamlining.• Standardized the Device History Record process by blending best practices among the four managing Device History Record desks and providing clear expectations as per customer requirements.• Completed all Continuous Improvement projects on time utilizing the Six Sigma A3, process mapping, Root Cause Analysis and process flows for problem resolution, creating more streamlined processes with Quality and Safety built into the plan in compliance with ISO 13485 and ISO14971.• Member of Safety Team conducting audits of facility and potential safety hazards, including storage and warehousing of chemicals, job function and office ergonomics and general safety habits.
  • Pfizer
    Distribution Line Supervisor- Trainer
    Pfizer Jan 2021 - Oct 2021
    New York, New York, Us
    • Led and instructed employees in compliantly and safely receiving and processing inbound deliveries of Covid-19 vaccines in an efficient manner, reducing temperature excursion risk during processing and storage.• Led and instructed employees in packaging and processing Covid-19 vaccine orders for customers including operation of automated dry ice dispensing equipment and proper disposal of dry ice.• Picked and processed medication orders assuring accuracy and quality for customer items and packaged for delivery to customer.• Safely operated material handling equipment for inventory movement, location replenishment and order fulfillment.• Highly involved in continuous improvement efforts• Member of Pfizer Safety Council, teaching and monitoring safety compliance for Distribution Center associates including forklift safety and dry ice handling.• Accepted a promotional opportunity with Jabil Healthcare for future growth.
  • Ampcus Inc
    Quality, Safety, Training And Compliance Consulting
    Ampcus Inc Nov 2019 - Jan 2021
    Chantilly, Va, Us
    Assist clients resolve business compliance issues through guidance and consulting with regards to:• CAPA/Complaints• Quality/Training/Compliance• Safety• Review and Audit Preparation• Quality Systems• Accepted a full time permanent role with Pfizer for distribution of vaccines.
  • Medline Industries, Inc.
    Training And Production Supervisor
    Medline Industries, Inc. May 2018 - Aug 2019
    Northfield, Il, Us
    • Created, implemented, and managed the site-training program, policies and practices which did not exist and performed New Employee Orientation with an emphasis on GMP, GDP and Safety. • Monitored Optimal Equipment Efficiency (OEE) and reduced downtime by training personnel on proper machine operation and monitoring all aspects of mechanical breakdowns.• Improved business efficiencies by collaborating with site engineering, mechanic teams and purchasing the proper equipment necessary, for all employees to perform their tasks compliantly as per ISO13485.• Created and completed process deviations in a timely and compliant manner reducing risk and determining proper impact analysis across the operation.• Compliantly performed CAPA and Root Cause analysis for non-Conformities, creating a downward trend in yearly discrepancies, resulting in a sixty five percent reduction and identifying true Root Cause, allowing for proper fixes to be implemented. • Updated and created procedures to reflect current processes including updates to all impacted documents cross functionally and Continuous Improvement initiatives.• Accepted consultant role for better work life balance to deal with family matters
  • Abbvie
    Quality And Training Specialist
    Abbvie Jan 2013 - Oct 2018
    North Chicago, Illinois, Us
    Multiple Roles held:Quality Assurance Analyst-Pharmacy Regulatory Compliance• Successfully maintained Pharmacy and Controlled Drug licensing compliance for all fifty states by tracking all licenses, including renewal application submission, ensuring compliance against all state laws (Pharmacy RA) with no business interruptions. QA Doc Center Manger/ Training Specialist• Managed the Pharmacy Document Center and change process for Quality System Documents and maintained the Quality System in audit readiness status.• Facilitated training and designed training for the document change control process.• Developed and implemented trainer qualification, training review, change control and training effectiveness to enhance compliance and training effectiveness per 21 CFR 820, 210 and 211.Quality Assurance/ Training Specialist • Managed and streamlined training system effectiveness by implementing Curricula processes in the Isotrain Learning Management System (LMS), creating efficiencies with Onboarding and Off-boarding of employees and accuracy of training curricula assigned to personnel for function specific jobs and tasks.• Functioned as the LMS and SharePoint administrator assuring compliance, branding and collaboration communications met all company standards.• Performed Complaint management and communicated with all levels of sales. marketing and Pharmacovigilance for metrics of Post Market Surveillance initiatives.
  • Henry Broch Foods
    Quality Assurance/Quality Control Supervisor
    Henry Broch Foods Jan 2018 - May 2018
    Waukegan, Illinois, Us
    • Trained and supervised department employees to ensure optimum competency, commitment, and performance, including housekeeping, pest control and sanitation, resulting in compliant Audits by customers and regulatory boards as per SFQ regulations.• Ensured corrective measures were taken to maintain quality standards (CAPA/Complaint handling), elevating audit results and reducing customer complaints.• Monitored and evaluated food safety risks including Hazard Analysis Critical Control Points (HACCP) resulting in zero cross contamination test results.• Conducted GMP, Food Safety Audits and maintain all required documentation including monitoring and enhancing Pest Control compliance and results.• Accepted promotional opportunity with Medline Industries
  • Abbott
    Quality And Training Specialist
    Abbott Jun 1997 - Dec 2012
    Abbott Park, Illinois, Us
    Multiple Roles Held:Quality and Regulatory Training Coordinator• Managed the logistical coordination of CAPA and Complaint training events globally, record management, vendor contract and SOW negotiation, creation of training presentations and facilitation of classes including creating efficiencies in the overall process for global class coordination.Supply Chain-Distribution Quality Assurance• Processed CAPA and Complaint Investigations for the Chicago Distribution Center and managed all controlled drug auditing and Cold Chain events, including stability investigation and packaging design input. Coordinated product recall events with manufacturing and supply chain.Supply Chain-Training Coordinator• Managed the Training program for Twenty-Seven departments under Supply Chain and 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.Planning and Reimbursement Specialist/Materials ManagementProcessed special chemical shipments for laboratory scientist requests, created HazMat and Export Documentation for global shipment requests and managed inventory for the hospital products division.• Managed the logistical project for DMSO and THF chemical recycling to and from Puerto Rico and corrected a billing error, resulting in a vendor refund of $6000.• Controlled the logistical coordination of solvent transportation from Abbott Chemical Plant in Puerto Rico and Chicago Recycling Center, including review and approval of payment for transportation services.• Utilizing Six Sigma tools, reduced the number of tankers used for the recycling project and created a budgetary reduction of $360,000 for the year.Compliant in a class 100 clean room.

Ed Garcia Skills

Returns Quality Management Supplies Payments Vendors Windows Sales Gxp Supply Chain Management Change Control Rework Performance Metrics Isotrain Trackwise U.s. Food And Drug Administration Sop Development Quality Auditing Pumps Cross Functional Team Leadership Facilitation Clearances Developmental Commodity Management Dea Export Documentation Recycling Continuous Improvement Sop Metrics 21 Cfr Part 11 Spanish Leadership Auditing Office Equipment Powerpoint Learning Management Public Speaking Lean Manufacturing Sharepoint Financials Gmp Food Safety Software Documentation Team Leadership Validation Engineering Iso 9001 Strategy Supervision Inventory Declarations Microsoft Office Usda Rent Collection Aseptic Technique V&v Microsoft Excel Testing Training Customer Service Storage Contract Negotiation Intranet Corrective And Preventive Action Supply Documentation Project Management Scheduling Quality Control Reporting Agriculture Ops Capa Analysis Solvent Property Management Finalization Sap Gas Retail Sanitation Complaint Management Logistics International Clients Registration Negotiation Catering System Administration Quality Assurance Regulatory Requirements Operations Duplication Quality System Instructor Led Training Maintenance Webex Warehouse Management Marketing Adm Document Management Change Management Paint Sow Courses Training Delivery Remediation Plumbing Business Process Improvement Classroom Aes Data Migration Spd Forklift Operation Internal Audit Six Sigma Packaging Distribution Scales Creativity Skills Food Lotus Notes Reviews Records Cold Chain Collections Process Improvement Materials Medical Devices Outlook Continuing Education Microsoft Word Complaint Investigations Analytical Skill Rico Business Process Administration Manufacturing Financial Reporting Sampling Scientists Flooring Pharmaceutical Industry Problem Solving Supply Chain Calibration Order Processing Fda Recording Product Quality

Ed Garcia Education Details

  • Gateway Technical College
    Gateway Technical College
    Leadership Development Program
  • College Of Lake County
    College Of Lake County
    Management And Operations
  • Us Navy
    Us Navy

Frequently Asked Questions about Ed Garcia

What company does Ed Garcia work for?

Ed Garcia works for Kem Krest

What is Ed Garcia's role at the current company?

Ed Garcia's current role is Quality and Continuous Improvement Manager.

What is Ed Garcia's email address?

Ed Garcia's email address is eg****@****rma.net

What schools did Ed Garcia attend?

Ed Garcia attended Gateway Technical College, College Of Lake County, Us Navy.

What are some of Ed Garcia's interests?

Ed Garcia has interest in Social Services, Children, Civil Rights And Social Action, Politics, Environment, Education, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Health.

What skills is Ed Garcia known for?

Ed Garcia has skills like Returns, Quality Management, Supplies, Payments, Vendors, Windows, Sales, Gxp, Supply Chain Management, Change Control, Rework, Performance Metrics.

Who are Ed Garcia's colleagues?

Ed Garcia's colleagues are Lori Fenton, Rozanne Moreno, Tara Hall, Mike Mcfarland, Autumn Morgan, Gabby Fuentes, Kelly Catrell.

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