SUMMARY OF QUALIFICATION

Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry

Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC

Extensive experience on Root Cause analysis methodology and implementation of Robust Corrective and Preventive Actions (CAPA)

Extensive experience in managing and reducing customer complaints by thorough Root Cause Investigation and developing and implementing a robust Corrective and Preventive Actions (CAPA)

Extensive experience in managing the Supplier/ Vendor qualification program, Supplier Scorecard ratings and vendor audit to ensure the vendors adhere to the regulatory requirements and to investigate, analyze and resolve supplier quality problems

Extensive experience in managing the Supplier Quality metrics such as:

Non-Conformance Tracking (MRB)

Supplier Corrective Action Requests (SCAR)

Corrective Action and Preventive Action (CAPA)

Extensive experience in Validation from the Process Design Plan through the completion in accordance with cGMP's; (IQ, OQ and PQ)

Extensive experience in Risk Analysis, Gantt charts, Statistical Sampling Plan and Mistake Proofing/Poka Yoke.

Extensive experience in Food safety plan, allergen handling and control, and HACCP plan

Extensive experience managing the activities of the Incoming Quality Control (IQC) of Raw materials to ensure incoming raw materials, components and contract manufactured products meet their approved specifications and regulatory requirements

Extensive experience in managing the internal quality and housekeeping audits to assure manufacturing facility conforms to regulatory standard and manufacturing requirements

Extensive experience in Quality activities for development, design, distribution and/or manufacturing of various products to ensure high level of process and product quality regarding Pharmaceutical, Medical Device, Food industry, Nutritional, and Skin Care products

Extensive experience in product development projects, including validation plans, verification of the label and stability studies

Extensive experience in managing quality teams, processes, and initiatives to drive continuous improvements, better quality control and production efforts

Extensive experience managing calibration program to ensure that all equipment’s that require calibration are calibrated on timely manner and adhere to regulatory requirements

Extensive experience in real time and accelerated stability study

Extensive experience in problem-solving and troubleshooting skills. Proven ability to exhibit an energetic, positive, approach to teamwork

EDUCATION BACKGROUND:

1980 Bachelor of Science in Chemical Engineering, Adamson University,

Manila, Philippines

1981 Passed the Philippine Chemical Engineering Board Exam

SEMINARS AND TRAINING:

5/2016 Lean 101: Introduction to Lean and Continuous Improvement

Alpha Nova Consulting, Dallas, TX

4/2015 HACCP Food Safety Training

2/2011 Avoiding FDA 483 Observation by Identifying the Root Cause of

Deviation

5/2010 FMCNA Fresenius 2008 K Dialysis System Technical Training

Class

5/2010 Advanced Microsoft Excel by Fred Pryor Seminars

3/2010 Calibration and Qualification in Analytical Laboratories by

Compliance on Line”

12/2009 QIMT1210: Product Quality and Measurement by QUAMETEC

Institute of measurement Technology

12/2009 QIMT0810: Introduction to International Metrology by

QUAMETEC Institute of measurement Technology

3/2009 Granuflo Dissolution System Technical Training Class by Fresenius

USA, INC

9/2008 Jumpstart in Project Management by ASPE Technology

12/2007 Certified RABQSA ISO 13485:2003 Lead Auditor by AQS

Management System, Inc. # Q10573 – Passed Exam

11/2007 Quality System Requirement and Industry practice by

Association for Advancement of Medical Instrumentation (AAMI)

FDA Quality System Regulation – Passed the Course exam

5/2007 HACCP Food Safety Training

7/2006 Six Sigma Green Belt Certified

Value Train, Dallas, TX

4/2006 Apollo Root Cause Analysis for Practitioners

Apollo Associated Service Inc.

Dallas, TX

9/2005 Quality Tools Basic Training

Fresenius Medical Care

Irving, TX

3/23006 Inter Auditing Basic Class

Fresenius Medical Care

Irving, TX

10/2003 LAL Methodology and Application Workshop

Associate of CAPE COD Houston, TX

10/2003 Hemodialysis Training Course

Associate of CAPE COD

Houston, TX

10/2001 Process Auditing for ISO 9001-2000

STAT-A-Matrix Institute

Dallas, TX

07/1994 First Line Leadership

Tyson Foods, garland, TX

06/1994 University of Arkansas

Division of Continuing Education

Tyson Foods Advance workshop on Microbiology

12/1993 Tyson Foods Total Quality Management Seminar

Process Improvement Training

05/1993 University of Arkansas

Division of Continuing Education

Tyson Foods workshop on Microbiology

ACHIEVEMENTS AND AWARDS:

7/2006 Fresenius Medical Care, Irving, TX Certificate of Achievement

for Successful Completion of Lean Six Sigma Dry Acid Yield

Project

Position: Associate Team Member

2/2010 Fresenius Medical Care, Irving, TX

Successfully completed the Project: Conversion of

Rejected Dry Acid concentrate to Liquid Acid concentrate

Performed the IQ/OQ and Process Validation

Wrote the SOPs of the process

7/2004 Fresenius Medical Care, Irving, TX

Employee Outstanding Performance Award

2/1993 Tyson Foods War on Waste, Garland, TX

Winner 2 Grand Idea Awards and Certificate of Appreciation Award

PROFESSIONAL EXPERIENCE:

United1 labs International (July 2014 – February 2017)

1541 Champion Drive

Carrolton, TX 75006

Telephone No. 972-***-****

Quality Director

Manages the activities of the Incoming Quality Control (IQC) department to ensure incoming raw materials, components and contract manufactured products meet their approved specifications or other regulatory requirements. Manage the QC inspectors and lab techs

Manage the Supplier/ Vendor qualification program, Supplier Scorecard ratings and vendor audit to assure continued Supplier conformance to the quality system requirements

Manage the internal quality and housekeeping audits to ensure manufacturing facility conforms to regulatory standard and manufacturing requirements

Manage the Nonconformance and Customer Complaint Metrics and trending analysis

Responsible for the development, implementation, and strict adherence to a quality program. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of all products

Manage, develop and implement the HACCP plan for each manufacturing line and process

Manage the customer complaint; Resolves any quality issues regarding customer’s complaint by thorough Root Cause Investigation and developing and implementing a robust corrective and preventive actions or CAPA to prevent the recurrence of the nonconformance

Perform investigations of any incidents where manufacturing practices fail to comply with required standards and alerts upper management to these incidents and the resulting follow up investigations. Prepare and implement corrective actions and or CAPA if needed and verify the effectiveness of the corrective actions

Manage the incoming raw materials and components including applications and labeling (Code of Federal Regulations, Nutritional Facts Panels)

Receives and reviews all customer satisfaction surveys and customer contacts and complaints. Prepare complaint trends and product/component failure analysis

Analyze process, work operation, complaint, quality records and other source of data to identify existing or potential source of failure. Where failures and potential failures are identified, recommend solution for problem resolution

Responsible for providing cGMP, OSHA, SOP, Regulatory Requirements training to production and Quality personnel to ensure continual adherence to Regulatory Requirements and OSHA requirements

Coordinate, help and perform quality education and training to entire Quality and production staff to ensure adherence to regulatory and legal requirements.

Monitor activities to ensure compliance with core quality measures; Gather, analyze and manage quality related data

Responsible for the decision over the shipment of any product or products and accepts the responsibility for products being in compliance with all regulatory and company standards

Reviews and resolves quality control problems/concerns with the Quality Control Manager and others including vendors, customers, quality control personnel, and any personnel related to production. Coordinates and assists with vendor inspections

Periodically inspects completed quality control checklists, forms, and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards

Schedules and performs Internal quality audits and reports findings to the President, Quality department and Production /Operations; develops and implement corrective action plans and ensures timely resolution of findings

Perform IQ/OQ, Process and Performance Validation on each production process and equipment / instruments

Prepares reports and other documentation required by regulatory agencies and to support the quality function

Manage calibration program to ensure that all equipment’s that require calibration are calibrated on timely manner and adhere to regulatory requirements. Maintain the calibration records are constantly and properly updated and easily available for future referencing

Manage the waste water effluent treatment and ordering of treatment chemical.

Manage the temperature and humidity data collection from the coolers, warehouses, processing and filling rooms to ensure they are constantly and properly updated and easily available for future referencing

Fresenius Medical Care (May 2001- July 2014)

5201 Regent Blvd.

Irving, TX 75063

Telephone No. 972-***-****

Promoted to Quality System Engineer (8/2007- 7/2014)

Manage the customer complaint, environmental monitoring, and Nonconformance metric trending plan and investigation

Manage the stability study and develop and implement the HACCP plan for each manufacturing line and process

Responsible for the calibration schedule and in house calibration of the process equipment, and test instrument.

Manage internal and external supplier audit

Performs Periodic validation review

Analyze process, work operation, complaint, quality records and other source of data to identify existing or potential source of failure. Where failures and potential failures are identified, recommend solution for problem resolution.

Responsible for the problem solving of the non-conformance and implementation of Corrective and Preventive action (CAPA).

Performs internal and external supplier audit

Performs Periodic process review of the validation protocol

Manage the customer product complaint

Perform, Draft, review and conduct IQ/OQ, PQ and method validation

Analyze process, work operation, complaint, quality records and other source of data to identify existing or potential source of failure. Where failures and potential failures are identified, recommend solution for problem resolution

Promoted to Assistant QS Lab Supervisor (January 2004- 8/2007)

Responsible for testing, and releasing of Incoming Raw Materials.

Generate and Verify Finished Product lab. Test Report for Liquid Line and Dry Line.

Responsible for checking and reviewing laboratory test reports.

Responsible for Process Batch adjustment and assist in Validation of new lab Procedure.

Responsible for Lab. tech scheduling of work assignment, lab. Equipment preventive maintenance and trouble shooting and special testing.

Responsible for OOS Lab Investigation and analyzing data to identify root cause of OOS

Responsible for keeping QS Lab. inventories.

Evaluate new test methodologies and instrumentation

Responsible for training new Lab. tech and perform Internal Audit.

Coordinate with Production about the outcome of each test to ensure good product quality.

QS Lab Tech. (May 2001- January 2004)

Responsible for testing of Incoming Raw Materials, In Process Product and Finished Product.

Performed Environmental Air Monitoring of Liquid Line Packaging line.

Perform Line clearance and daily audit.

Assist in collecting raw materials, printing and verifying labels.

Was promoted to QS Lead Analyst

CBI Lab, Division of Thermoelectron (Aug. 1997- May 2001

2055 C Luna Road

Carrolton, TX 75006

QC supervisor/Analyst- Promoted

Responsible for Collecting, testing and releasing of incoming Raw Materials, components, in process product and finished goods sample. Perform Statistical Process Chart on finished goods test data

Perform pre-op swabbing, and sanitary inspection of processing equipment prior to operation.

Implement GMP to Production workers

Coordinate with Production about the outcome of each test to ensure good product.

Coordinate with sales rep. and customers regarding product complaint

Monitor the sanitary condition of warehouse.

Tyson Food (Dec. 1988- Aug. 1998)

113 Range Drive

Garland, TX 75040

Promoted to Assistant QS lab supervisor (Nov. 1988-Aug. 1997)

Perform micro and chemical testing of raw materials, in line process products and finished products.

Responsible for ordering of all lab. Supplies. Prepare and standardize media and reagents

Conduct pre-op swabs and visual inspection of processing equipment prior to start up.

Evaluate and do cost analysis on new lab. Procedure.

Maintain the proper concentration of Central Sanitizer system

Responsible for preparation of QS Weekly Activity Report

Perform environmental swabbing and Implement GMP to Production workers

Monitor the sanitary condition of Warehouse, coolers and freezers.

QS Inspector (Dec. 1986- Nov. 1988)

Perform pre-op inspection of processing area and equipment, raw materials and components prior to operation

Inspect sanitary condition of warehouse, coolers and freezers.

Implement Good Manufacturing Practices to Production workers.

Collect and inspect incoming raw materials, in line product and finished product sample for micro and chemical testing. Perform Statistical Process chart on in process and finished good test data

Perform sensory test on fully cooked finished product and coordinate with production about the outcome of each test.

Monitor sanitary condition of processing room and equipment and Perform Operational swabs on processing equipment

Responsible for testing in process product, incoming components. Perform Statistical Process Chart on test data

Was promoted to QS Lab. Analyst

Yanbu Power Plant and Desalination Plant (Aug. 1983-Aug. 1985)

Kingdom of Saudi Arabia

Plant Chemist

Extensive experience in Water testing and oil testing

Maintain the Chemistry lab, including the ordering of Chemical and equipment

Internally inspect evaporator, boiler units and heat recovery steam generator

Recommend changes in the dosing rate and concentration of treatment chemicals

Prepare and supervise acid cleaning procedure for power plant and Desalination plant

Prepare and schedule wet and dry storage of boiler drum

Prepare reports about the outcome of each test and give technical input to Operation Engineer

Nestle Philippines (April 1980 – Aug. 1983)

Laboratory Supervisor

Conduct routine and special Lab testing

Verify results of all quality data

Supervising, training and evaluating lab team

Coordinate with production about the outcome of each test to ensure good product quality.

Maintain lab supplies inventory

REFERENCES:

Available upon request

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