Pedro R. Sanchez BS, JD, SSBBC

Tel:724-***-****, Email: ac13q4@r.postjobfree.com

Overview

Over thirty years of experience in supervision and management in Quality, QSR, Compliance and Regulations. Last ten years with emphasis in Functional Analysis, Lead Auditing and Quality Assurance. Lean Six Sigma Black Belt Certified. Conducted, managed and assisted internal audits per applicable regulations and Standard Operating Procedures. Also managed corrective actions, findings and compliance activities. Maintained internal Process, Quality, and PM documentation libraries. Six Sigma Lean application to Master Plan validation activities of new plant additions. Overall, plus ten years’ experience in supervision and supply chain management (SCM). Internal MX Corp. Lean Green Belt certifications. Experience using tools such as Control Plans, FMEAs, DOE, and PPAP. Able to communicate advanced quality concepts to all types of audiences. Knowledge of statistical analysis tools. Performed as CAPA Remediation Consultant, with 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. Risk Assessment Surveyor, On-site Supplier Quality Management Approval and Certifications, Supplier Quality Engineer Lead Auditor, Value Stream Mapping. PM for SAP QMRIT Regional Implementation. CAPA combined experience within three regulated industries of fifteen years.

Auditing experience since 1991 to present. Regulatory bodies and major regulations under which I have participated and or maintained quality libraries and systems; 21CFR, cGMP’s, cGLP’s, GDP’s, ISO 9000, QS 9000, TS14000, TS 16949, AIB, SQF, FDA, USDA, FSMA, HACCP, FAA covering food, electrical-automotive, metallurgical-defense, medical device, government-administrative /, IT, and non profit _

Can Perform GAP analysis with the intention of resolution for new product, processes and or new physical plant validations of establishment requirements.

Can initiate CAPAs, determine root cause, closing and implementing change if needed

Inspectional Objectives, Decision Flow Chart Narrative, Medical Device Reporting, Inspectional Objectives, Corrections & Removals, Medical Device Tracking

Automotive Industry eexperience using tools such as Control Plans, FMEAs, DOE and PPAP

Development of Quality Management Systems from the ground up.

Knowledge of ISO 9000 and ISO13485 as it relates to IQ/OQ/PQ activities and LIMS

Supplier Quality Audits / Internal, External and Third Party

Education

Pontifical Catholic University

Juris Doctor Degree

Ponce, PR

Pontifical Catholic University

Finance – Extended studies courses

Ponce, PR

University of Puerto Rico

Bachelor of Science

Major in Biology

Río Piedras, PR

Trainings/ Continued Education

2011

International Society for Six Sigma Certification

Monroeville, PA

2010

International HACCP Alliance/Penn State University

Fundamentals of HACCP

Callery, PA

2006

Lean Manufacturing/KAIZENBLITZ

Sta. Isabel, PR

2005

ASQ Certified Auditor Academia

Sta. Isabel, PR

1992

ASQE Certified Quality Technician Academia

Ponce, PR

Experience

January 2017 – June 2017

Quality Process Specialists

Bayer Corporation / Randstad Inc.

Sterile Disposables –Production Process, Safety and 5S Assessment

Winter Solstice 2016- Cross functional 5 S team member

Assess current business process for waste elimination feasibility, as a means for improvement b via 5S methodology.

Remaining period of time assisted in the daily manufacturing process active in 3rd shift effort in 3rd shift.

Indianola, PA

February 2015 – March 2016

Echmon Corporation (Non-Profit)

Aibonito, PR

Quality Process Functional Specialists/ Lean Process Six Sigma

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 -Educational 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.

Experience

February 2014 – September 2014

Beacon Engineering Resources, Inc.

McKees Rock, PA

Quality Assurance Auditor and In Process / Internal Audits Trainer

Implement and establish an Internal Audits program as part of Corporate’s Quality Assurance Program.

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 certification 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

Feb to Aug 2012

Heinz North America

Warrendale, PA

HACCP Audit- Document Reviewer

Main responsibilities include the systematic verification of the Heinz North America 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 Reference tables, for the different operations to use as templates to accurately complete the respective HACCP analysis.

Jun-Aug 2011

Allegheny County Department of Human Services

Pittsburgh, PA

PM Consultant – Six Sigma Black Belt

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.

June 2009- June 2010

Charlie’s Specialties/B&K Manufacturing

Hermitage, PA

Callery, PA

Implementation Regulations Coordinator-Consultant

Lead Quality Regulations and Implementations Manager

Coordinate AIB Audit Certification 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 incorporate 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 training 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 certifications. Maintenance of Approved Supplier Matrixes.

Responsible for handling customer complaints (CAPA), by establishing a QSR, FDA compliant SOP’s, and subsequent training

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 Trainings

Nov.2007 –March 2009

Procesadora Campo Fresco

Sta. Isabel, PR

Quality Technician

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.

Oct 2006 – July 2007

Consultant

Doral City, FL

Consultant - Risk Assessment Surveyor

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.

Consultant - Internal Auditor

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 certification 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.

Oct 2005 – Oct 2006

Hamilton Sundstrand

Sta. Isabel, PR

Internal Auditor

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.

June 1991 – June 2004

Molex Caribe, Inc.

Ponce, PR

QN Coordinator

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

PM -QM SAP Regional Implementation Team Leader, QE

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 training in SAP Basic Navigation to all users and QM Navigation to authorized personnel

Quality Auditor

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 training 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 Certifications.

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.

1988 – 1991

Van Camps Sea Food National Packing

Ponce, PR

Plant Cleaning Crew Supervisor

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

1984 – 1987

Orange Crush of Puerto Rico

Bayamon, PR

Syrup Room Supervisor

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.

1981 – 1984

Serralles Distillery

Ponce, PR

Laboratory Technician

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.

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 Memberships

American Society for Quality.

Latin Counselor/ Notary Society-Delta Zeta Phi

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