Mar a Gisela G mez Luna

**** ****** ****** *****

Mason, OH 45040

787-***-**** ab8tnk@r.postjobfree.com

PROFESSIONAL PROFILE

Professional Industrial Engineer (PE) with extensive experience

implementing suppliers' quality and management processes within regulated

industry. Comprehensive background in quality assurance and regulatory

systems including successful interactions with regulatory agencies (FDA,

ANVISA, KFDA [Korean Food and Drug Administration], and MHRA). Trustworthy

professional with exceptional interpersonal, analytical, and negotiating

skills. Consistently exceeds goals. Strong commitment to continuous

improvement. Bilingual English / Spanish.

Areas of expertise include

Customer Service Internal / External Audits (ASQ-CQA

Certified)

Cost Reduction Statistical Analysis

EXPERIENCE

PFIZER PHARMACEUTICALS LLC, Vega Baja, PR 2002 - 2012

Quality Operations Technical Specialist, Senior, Barceloneta, PR 2008 -

2012

Led Suppliers Audit Program for Pfizer Puerto Rico and Reduced Testing

Program for Pfizer Barceloneta including completion of risk assessments,

investigations, and CAPAs related to suppliers and materials.

. Increased suppliers' audit completion rate from 64% to 100% during 1st

year of implementation and leadership by developing program for

management of suppliers' audits for 3 Pfizer sites in PR including

development of standard procedures, scheduling systems, and tracking of

key metrics within program.

. Led reduced Testing Program (chemical and microbiological assays) for

Barceloneta site which resulted in elimination of 12 permanent technician

positions in Raw Material laboratory.

. Championed risk assessment process resulting in successful completion of

investigations and release of products with potential quality defects.

. Successfully implemented new quality standards for handling suppliers by

leading team of representatives from 6 Pfizer sites in Puerto Rico and

modifying procedures; presented recommended changes to Pfizer Quality

Leadership Team. As result, role was created at each site to handle new

requirements within suppliers' Quality programs.

. Developed and led multifunctional team in management of changes in raw

materials processing and packaging, resulting in 30+ changes successfully

handled and implemented on bi-weekly basis.

. Served as key player in all regulatory agency audits received at site

(including FDA, ANVISA, KFDA, MHRA, etc.), resulting in successful

communication of daily audit results to Pfizer organization worldwide

within 1 business day.

Quality Assurance Technical Specialist, Caguas, PR 2007 - 2008

Evaluated Batch Records for appropriate disposition of manufactured product

on timely basis including evaluation and closing of investigations,

tracking stability program, and submitting data for APRs preparation.

. Within 1st 3 months in position, led Kaizen Event (RFT) for reduction of

disposition time, resulting in improvement of layout of disposition

personnel offices and achieving improvement in lead time of 3 days.

QA Technical Specialist (Project Leader), Barceloneta, PR 2007

Led Raw Materials / Packaging Components Testing Reduction Initiative

including Top 10 Raw Materials and Packaging Materials used by Barceloneta,

Caguas, and Vega Baja sites.

Guided multi-functional team integrated by personnel from 3 Pfizer sites,

resulting in savings of $1.2M and recognition as 1 of top 3 savings

initiatives within PR Region 2007.

QA Technical Specialist (Vendor Program Leader), Arecibo, PR 2002 - 2007

Developed and led Suppliers Management Program including supplier audits,

quality issue resolutions, supplier changes, materials regulatory

certifications, reduced testing program, and material dispositions.

. Implemented new role for suppliers' quality handling which resulted in

achievement of 100% suppliers audits completion during 5 consecutive

years and zero delays in supplier changes implementation.

Mar a Gisela G mez Luna Page Two

PFIZER PHARMACEUTICALS LLC (Continued)

. Coordinated and led Suppliers Quality Awareness activity with

participation of all key suppliers to explain impact of materials quality

issues and investigations procedures. As result, obtained 80% decrease

in quality issues and 100% closure of investigations by due date.

. Created and led Reduced Testing program which resulted in elimination of

5 technician roles at Raw Material laboratory.

PROCTER & GAMBLE, Cayey, PR 1999 - 2002

Materials Quality / TSO Manager / Leader

Supervised Materials Quality group focused on elimination of quality

issues; led suppliers' negotiations (SLEAs) and performance follow-up

during monthly scorecards reviews.

. Developed site NCR's system to document materials issues, establish

corrective / preventive actions, and follow-up until closing. Project

resulted in successful communication tool between production and team

which supported achievement of goal of less than 0.5% reliability issues

due to materials quality.

. Guided site Materials Savings group and Material Cost Variance Analysis

group obtaining savings of $1.5M year; project was conducted applying IWS

methodology including loss analysis.

. From planning perspective, led initiatives for introduction of new

products to site including verification of inventory levels, new

supplier's negotiations, demands verifications, and materials

specifications creation.

ELECTRONIC MANUFACTURING SERVICES, Mayaguez, PR 1998

Process and Project Engineer (COOP)

Applied general Industrial Engineering principles including: layouts, time

studies, line balances, capacity analysis, lot sizes, and setup times

reduction for improvement during production of electronic board devices.

. Completely redesigned shipping area which reduced lead time by 5 days.

. Led project documenting work instructions and procedures which resulted

in achievement of ISO 9002 certification.

EDUCATION

. BS, Industrial Engineering, University of Puerto Rico, Mayaguez, PR

LICENSE AND CERTIFICATION

Professional Engineering License No. 19321 Kaizen Leader

Pfizer QSTS Site Quality Auditor Right First Time Method 1 Training (Yellow

Belt)

ASQ-Certified Quality Auditor (CQA) Six Sigma Green Belt Trained (70% of

Certification No. 41833 Certification Completed)

SKILLS

. MS Office, MS Project, Lotus Notes, MS Outlook, SAP, MAPS, cGMPs, ISO

9002, Trackwise, Minitab

. Bilingual (Spanish / English)

PROFESSIONAL DEVELOPMENT

Right First Time Methodology Train the Trainer

Auditing and Qualifying Suppliers and Auditing Software Vendors and Data

Vendors Providers

Preparing for an FDA Inspection Narrow Web Label Technology

Blow Molding Technology Corrugate Packaging Technology

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