SUMMARY:

• Assess current business process for waste elimination feasibility, as a means for improvement by use of six Sigma Lean Concepts, and Six Sigma tools. 30% overall improvement
• Mapping of current state preceded the development of questionnaires to be completed by random selection of users and external clients;
• Gathering statistical data to determine lead times, via evaluation of case scenario successful service time completion, efficiencies as well as conformity of current results with desired future state metrics. (Improve system effectiveness.
• Creation of current process state - future process state Visio mapping
• Opportunities for improvement were itemized, and test scenarios were run to assess degree of efficiency attained. Processes Improved -al services to children with specific learning disabilities, Humanitarian mission protocols to Dominican Republic and Haiti. Liaison procedures between food and groceries providers and food services agencies; less fortunate people kitchens. (Puerto Rico).
• Service Providers Matrixes update to conform latest government requirements per PR Department of State Office.

TECHNICAL SKILLS:

Skills and Abilities: Detail and quality orientated, excellent presentation skills. Excellent written and oral skills in both English and Spanish. Quality System functions: Document control, Quality engineering, Supplier Quality Management, Production Quality Control, Customer complaint handling, new product development support, Internal audit program. Great organizational and analytical skills. Team Builder. Project Management and Implementation skills. Knowledge in SAP, AS-400, JDE, MAXIMO, and Windows Word, Excel, PowerPoint and Access. Experienced in legal research engines usage such as Lexis- Nexis, Westlaw, Lexjuris.

PROFESSIONAL EXPERIENCE:

Confidential, McKees Rock, PA

Quality Assurance Auditor and In Process / Internal Audits Trainer

Responsibilities:

• Perform quality document audits in order to identify gaps in the execution of current business practices and manufacturing processes.
• Review documents, work instructions and manufacturing processes in the four principle production areas in order to identify the documentation needed to establish quality audit trails for each process.
• Create questionnaires and process sheets to be utilized in the internal audits of each area.
• Perform audits on selected processes and eliminate errors from forms and content in order to ensure future audits are more efficient and effective.
• Identified, selected and trained two internal employees for in each of the production areas as part of the Quality and Internal Audits Program of RECON TRANSTAR.
• Train each of the selected staff in good audit practices, inquiry/interview techniques, document evaluation, reconciliation of documents and practices against established processes and regulations, document control management, handling of controlled documents, good documentation practices, creation of cautionary statements and bulletins, presentation techniques and technical writing.
• Introduce each of the new auditors to the rigor of various audit cycles, covering all the PM and Process manufacturing areas. Train each auditor in brainstorming techniques, troubleshooting, etc.
• Perform other plant operational projects when designated by Plant Manager/Process Engineer such as: packaging, palletizing, carton dimensions evaluation, develop Attributes common language photograph library, together with second operation times calculation and estimation of costs incurred at different process levels

Confidential, Warrendale, PA

HACCP Document Reviewer

Responsibilities:

• Main responsibilities include the systematic verification of the Confidential factories HACCP plans in time for the yearly HACCP reassessment audits. A dual verification approach is being completed for each of the operations process steps, which include conformance to HNA Food Safety Corporate improved HACCP plans formats. Also the auditing of the HACCP Plans process steps defined as Critical Control Points, for these to reflect the latest scientific, regulations and industries justifications for each defined step. As a direct result of the documentation audit performed at Corporate, a series of sporadic visits to manufacturing sites was scheduled to follow up individual plants progress and improvements with the HACCP documentation files. In addition, a thorough visual evaluation of the identified processes was made, to physically evaluate the current documented CCP justifications, against the processes.
• Other activities performed include research of the different libraries and scientific food journals as a means of maintaining the latest data and information regarding food hazards, and latest industry trends in terms of process improvements. Aided in the edition of the HNA Corporate Food Safety Team /HACCP Food Hazard tables, for the different operations to use as templates to accurately complete the respective HACCP analysis.

Confidential, Pittsburgh, PA

PM Consultant - Six Sigma Black Belt

Responsibilities:

• Consultant to the Assistant Deputy Director of the Department of Human Services of Allegheny County. Initiative to improve or replace the DHS Request and Help Desk applications in order to establish and attain compliance with Service Level Agreements while increasing customer satisfaction at all levels.
• Identify Voice of Customer, Voice of Process (client), Problem Statement, Scope, & Objective
• Performed Measurement System Analysis, determined process capability, created process maps and determined priorities (value stream mapping).
• Performed Root Cause and Gap Analysis
• Utilized tools and statistics to analyze problem
• Created opportunities to improve the process
• Created Control Methods & Control Plans
• Identified efficiencies and deficiencies of the current applications.
• Identified and made recommendations for Policy, Business Processes and Application Improvements
• Made recommendations to replace the current application with a new Customer Relations Management (CRM) Solution under ITIL guidances.

Confidential, Hermitage, PA

Implementation Regulations Coordinator-Consultant

Responsibilities:

• Lead Quality Regulations and Implementations Manager
• Coordinate AIB Audit Program
• Implement, update and maintain the Plant Safety Food program
• Implement, manage and maintain the Records Retention Manual and corresponding records retention schedules, procedures, and processes in order to remain compliant with changing legal and regulatory requirements.
• Maintain a working knowledge of innovations and evolving industry best practices pertaining to records management and in corporate this into the plant’s records management program
• Perform business assessments, recommending cost effective improvements, and identify and implement solutions to records management issues.
• Develop and implement effective for employees.
• Perform Internal Audits to evaluate compliance with the Records Retention and related records management policies/procedures, and develop and assist with implementing corrective action where necessary.
• Developed and implemented Approved Vendor Matrix.
• Ensure adherence to disaster plans to ascertain Business Continuity in the event of a major disaster.
• Identify and protect historical records to preserve corporate data.
• Promote awareness of the Records Manager’s services, as well as other records management tools and software that may be useful to the various businesses.
• Implement tools to measure and monitor the ongoing development and effectiveness of the records management program.
• Develop and implement Quality Management System, (CI, TQM, QSR,GMP,CAPA,)
• Perform Gap Analysis of company quality system against AIB Prerequisite Guidelines.
• Develop Plant Procedures in accordance to AIB Food Safety Requirements, State and Federal Regulations.
• Develop Calibration Matrix and implement calibration system
• Responsible for the reconciliation of label data base against business program ingredients and nutrition facts list
• Perform Gap analysis between existing Standard Operating Procedures and Industry Requirements and Regulations
• Provide reports to Senior Management on the status of the records management program and any compliance related issues.
• Creation of Business Templates for Standard Operating Procedures and Quality Policy
• Establish written Standard Operating Procedures and quality policies.
• Responsible for analyzing current processes in conformance with Food Safety Programs Guidelines
• Develop and maintain Food Safety Program Cleaning Matrixes- Preventive Maintenance
• Identify and develop guidelines of the Hazard Analysis Critical Control Points Program
• Liaison between operations and OU Kosher Organization
• On site Supplier Quality Lead auditor for supplier approval and s. Maintenance of Approved Supplier Matrixes.
• Responsible for handling customer complaints (CAPA), by establishing a QSR, FDA compliant SOP’s, and subsequent
• Perform Root Cause Analysis/Implement and follow up on Corrective Actions, and subsequent protocol development for established corrective actions validations
• Conduct and report on inspections and audits of departments, vendors, and other contract facilities
• Review completed batch logs and shipment paperwork for accuracy, completeness, and adherence to guidelines and regulations/Conducted FDA, GMP and Food Safety s

Confidential

Quality Technician

Responsibilities:

• Responsible for conducting routine and non-routine analysis of materials.
• Compile data for documentation of test procedures and report abnormalities.
• Review data obtained for compliance with specifications and report abnormalities.
• Perform chemical tests to ensure the quality of different blends for acidity, viscosity and percent of solids.
• (TDS), sugar content, vitamin content and others.
• Preparation of lab solutions.
• Perform tests using Digital Refractometers and Titrations.
• Perform tests on packaging materials to ensure product integrity.
• Aseptic Closure Testing.
• Quality Auditing and Assurance. ADHOC CAPA team member initial isolation and identification of probable concerns in addition to Root Cause analysis, and Actions validations
• Ensure all products meet and/or exceed all standards of quality and excellence by following industries, customers and operational SOP procedures.

Confidential, Doral City, FL

Consultant - Risk Assessment Surveyor

Responsibilities:

• Intense validation and verification of no less than 80 CAPAS in six months with FDA 483 concerns and effectively bringing to a close successfully passing FDA inspection.
• Assisted in the overall task of establishing a guided framework for evaluating end customer’s on site process machinery as a means of identifying workstations for line clearance Risk Assessment, Severity Evaluation and Time Management.
• Interviewed area personnel to assess workstations under scope of project.
• Evaluate completed field survey questionnaires via protocol guidance in order to determine need for further actions on behalf of end customer; this by means of calculation, interpretation and analysis of results.
• Provide feedback of status of actual practices in terms of line clearance to core team as result of collected data from production areas together with recommendations as a result of such data interpretation, with the intention to direct customer efforts into assigning resources to those critically identified areas with opportunities for improvement.
• Perform as CAPA, OOT, OOS review and remediation consultant on a contract basis for a Miami Fla. Medical Device Company in preparation for Third Party and FDA follow up audits. Introduced for the first time to ISO 13485, QSIT - FDA Corrective Action subsystem. Team Horizon - Base Orientation- on identifying existing problems. Among them are acceptance activities, complaints, FDA-483 observations or warning letters, non-conformance or deviations, process monitoring data, and calibration and preventive maintenance records. Identifying existing problems. Among them acceptance activities, complaints, FDA-483 observations/warning letters, non-conformances, process monitoring data, calibration and preventive maintenance records.
• Additional activities included process monitoring data; calibration and preventive maintenance records; internal, external, supplier, a third-party audit; and thorough employee feedback.
• Responsibilities include: Relate to every internal process and procedure in order to assess compliance, completeness and correctness of FDA 483 complaints as well as CAPA’s resulting from External / Internal Audits documents to help prepare working site become ready for deadlines.
• SCAR/CAPA Root Cause tools, Metrology; physical measurements/tolerances determination of calculations and, inspection errors; blueprint interpretation, document numerical discrepancies from current in process document controls. Engineering changes verifications.
• Maintain daily interaction with Company’s Management at different levels in order to obtain necessary information, feedback and support to complete above mention tasks.
• Work closely with all levels of Management by means of maintaining effective communication and accountability of activities via different types of reports and status meetings.
• Report directly to EER Consultants President and dotted to Company Compliance and Quality Managers.

Confidential

Internal Auditor

Responsibilities:

• Responsible for performing and leading internal audits to the Puerto Rico Facilities as part of the QMS System to ensure compliance to in house specifications, standards and GMP’s.
• Electronic Quality System Documentation
• Responsible of document reconciliation to create a unified Internal Audit matrix to account for HS Electrical and Mechanical operations as one manufacturing site.
• In charge of the purging of material functionality within the Company Electrical Operation to make Corrective Actions to external and internal customer responses.
• Evaluate and oversee implementation of automated methods of managing and disposing records
• Belonged to operations Air Worthiness Response Team.

Confidential

QN Coordinator

Responsibilities:

• Managed Complaints System.(Electronic and Hard copies data base)
• Test the system in place to ensure that is in place by verifying the effectiveness of the CAPA activity. And it did not causes a worse situation. • Review the data sources that were used to identify the problem in the first place to ensure that the problem is not repeating (by reviewing current nonconformities and deviations)
• .•Check or confirm the status of any open CAPA items during internal audits.
• •Review pertinent data sources periodically to see whether there are trends that need to be acted upon.
• Clarify the issues that must be brought immediately to senior management’s attention. Define who is responsible for bringing them to management’s attention.
• •Any problem involving distributed product must be investigated with the utmost urgency—the problem may require a recall or notification to FDA.
• Isolated and contained suspect conditions in a timely manner by implementing interim corrective actions.
• Assigned tasks and followed up process owners in order to complete corrective actions as per 8D Discipline.
• Evaluate Root Cause Analysis in order to determine effectiveness of proposed actions.
• Coordination of internal and external quality concerns to Upper Management.
• Coordinate between Engineering, Manufacturing and Warehouse Departments in order to solve customer quality concerns and shipping discrepancies.
• Maintain and keep Corporate Metric Reporting to Local and Upper Management.
• Maintain QN Data Base

Confidential

PM -QM SAP Regional Implementation Team Leader

Responsibilities:

• Overall QM implementation, functional and QN coordinating experience of ten years.
• In charge of SAP implementation Quality Module for Caribbean Operations.
• Supervised up to fourteen employees during the implementation phase
• Gathered Business requirements and made recommendations to business processes.
• Developed standard and functional written procedures; ensured compliance to industry regulations and standards. Verified integration with PP, MM, SCM SD, functionalities.
• Performed Gap Assessment and Analysis between IBM Modular System Array (MSA) and SAP configuration to identify areas for improvement.
• Integrated the PP/MM Modules with QM /QN Corrective Action Preventive Action function
• Experience in Data Migration
• Functional and Technical experience in QM/PP/MM (five and a half years)
• Material Master (MM Module) identify and upload materials’ classifications under ROH, HALB or FERT
• Define and upload type of inspection to be performed in the QMS Module.
• Identify high runners for type of inspection.
• Performed tests in “sandbox” in conjunction with other plants.
• Developed documentation and provided in SAP Basic Navigation to all users and QM Navigation to authorized personnel
• Work closely with Product Engineers to solve manufacturing and packing issues.
• Responsible for creating and maintaining Product Specifications for Engineering and documentations according to ISO-9000 Standards, UL, CSA, CE.
• Participated in Continued Improvement Kaizen exercises in Green Belt capacity.
• Ensure product adherence to SOP’s, drawing specifications and blueprints libraries.
• Responsible of the creation of quality deficiency reports to internal and external customers.
• Perform as Internal Auditor, visiting plant lead auditor, and auditor guide for the Plant Manual System, on an assigned basis.
• Accountable for MRB inventories and proper disposition. Introduced in 1991 for the first time to FDA QSR system as benchmark for internal corrective actions Automotive 8D system.
• As member team was fundamental in developing SOP about CAPA fundamentals such as:
• Ensure the company’s SOPs covered benchmark relevant QSR requirements.
• Define the criteria for opening a CAPA request with provision of examples.
• Define all terms by implementing a written problem investigation SOP.
• Provide selected employees on root causes and perform thorough problem investigations. ASQ Academia s on Process auditing were first instituted to top managers and supervisors.
• Helped team members on identifying criteria for possible solutions by understanding the thoroughness of a CAPA investigation is in direct proportion of its potential risks to customers.
• Disseminate benchmark learnings across base line of CAPA team members as applied to the electronical and Automotive industries. Try to determine all root causes.
• Do not confuse corrective action and preventive action. Implement solutions that not only correct the immediate problem but also prevent the problem or any related problems or issues from occurring again.
• Move toward being able to identify and take action on possible problems before they become real ones
• On - site Supplier Quality Approval s.
• Implementation of claims system to both internal corporate plants and external customers.
• Quality assurance of manufacturing process.
• Inform Manufacturing, Product Engineers and Planners of product and process issues.

Confidential

Plant Cleaning Crew Supervisor

Responsibilities:

• Responsible for the supervision of 42 employees.
• Responsible for the allocation of resources.
• Accountable for the supervision of the cleaning crew in areas such as Fish Room, Packing Room and Autoclave to ensure FDA and Quality Standards for daily production.
• Responsible of inspection of areas prior to release for production.
• Ensure all areas meet Quality, Safety Standards and SOP’s

Confidential

Syrup Room Supervisor

Responsibilities:

• Responsible for the operation of laboratory with emphasis on preparation of soft drink formulation and respective blends.
• Responsible for the supervision of five technicians.
• Responsible for Quality Assurance of Raw Materials used; from the elaboration of blends up to the bottling of soft drinks.
• Other responsibilities included drafting of Q.A. Department Scheduling, acting as Line Production Supervisor in charge of eleven employees.

Confidential

Laboratory Technician

Responsibilities:

• Responsible for test frequencies of raw materials, through its fermentation intermediates and aging up to the final product.
• In charge of gathering laboratory data, as well as reports for obtaining diverse fermentation, distillation and plant efficiencies.
• Drafting of weekly and monthly inventories along with EPA fuel monthly report.