Quality Assurance Customer Service
Resume:
Mar a Gisela G mez Luna
Mason, OH 45040
787-***-**** *********@*****.***
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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