Project Manager Quality

Yrma Pacheco

Quality Management Systems . GMP Audits . Audit Management

Specialist in Supply Chain Quality for Biopharma, Electronic, Food-

Beverages, and Medical Devices

Good Manufacturing Practices (GMP) Expertise . Six Sigma Green Belt .

Inspection Equipment . CAPA

Deviations . SPC Tools . Lean Methods (QCD) . Injection Molding . Good

Documentation Practices

Languages: Bilingual Spanish and English . Conversational Italian

Accomplished leader of Quality Management Systems, QA, and Quality

Auditing. Complementary strengths in manufacturing operations and

electrical engineering. Expert at achieving quality compliance for

suppliers by establishing GMP, ISO, and documentation systems, starting

from scratch.

Manufacturing Operations Contract Manufacturing Organizations (CMOs)

QA and QC

Process Optimization Environment, Health and Safety (EHS) Team

Leadership and Motivation

Process Validation Capability Studies (Cpk)

RECENT TESTIMONIALS

"Yrma is a highly competent Quality professional who brings a passion for

her work to any organization

Matthew DeVito, Division Quality Manager, Parker Hannifin managed Yrma at

Parker Hannifin,

very detail oriented and knowledgeable about the development of

quality systems for biotech manufacturing operations."

Michael Ryan, Engineering Manager at Parker Hannifin

HIGHLIGHTS

. Quality Leader with 16 years of experience in project coordination,

Six Sigma, lean, SPC, and documentation.

. Achieved QMS compliance with GMP and led ISO 9001:2008 certification

initiative (Parker Hannifin).

. Expert at guiding suppliers on QMS modifications needed for GMP

compliance and final-customer approval.

. Implemented Supplier Qualification Program for Mitos Technologies -

unit of Parker Hannifin that makes high-purity fluid handling systems

for Biotech industry - including supplier audits, self-assessment,

quality agreements, and CAPA Assignments (Corrective and Preventive

Actions), Continuous Improvement, and QMS Follow-up.

- Reduce RPPM from more than 5000 to less than 500 in less than 2

years.

- Conducted GMP audits - both domestic and international- on

suppliers.

EDUCATION, PROFESSIONAL DEVELOPMENT, AND AFFILATIONS

Bachelor's Degree in Electrical Engineering, UNIVERSIDAD DE CARABOBO,

Valencia, Venezuela, 1994

Master's Coursework in Production and Quality, UNIVERSIDAD TECHNOLOGICA DEL

CENTRO Valencia, Venezuela, 2000

Certified Green Belt Six Sigma, SONY MUSIC, New Jersey, 2000

American Society for Quality (ASQ)

RECENT EXPERIENCE

PARKER HANNIFIN / MITOS BIOTECH, Phoenixville PA 2007-2011

Unit of global Parker Hannifin Corporation that manufactures fluid-handling

products and systems that meet high-purity requirements of the biotech

industry, - tubing and hose, valves, and molded components - $9M annual

revenues and 40 employees.

Quality Assurance Leader and Quality Engineer

Brought on board to resolve quality issues, and apply root cause analysis

to drive corrective and preventive actions (CAPA). Managed 5 QA and QC

professionals in Quality Department.

. Summary of Top Results:

- Reduced RPPM (Returned parts per millions) from 5860 to 486 in less

than two years.

- Implemented process improvements that reduced batch-record

production and inspection times by 15%.

- Increased productivity 10% by integrating quality & inspection into

production and reducing cycle time.

- Developed and validated along with the IT group a new software that

comply with GMP guidelines for label creation and Certificate of

Conformances, reducing packaging time in 10%.

. Summary of Key Actions:

- Performed Cpk studies for key products and processes, which helped

minimize continuous inspection.

- Drove actions that achieved ISO 9001:2008 certifications, while

meeting CRF 820 and GMP requirements. Collaborated with

Engineering, Purchasing, Sales, and Manufacturing.

- Established new systems that performed data collection, trending,

and troubleshooting, in compliance with GMP and 21CFR 820, 21CFR210

and CFR211 for all the departments.

- Reviewed manufacturing batch records; coordinated internal audits;

reviewed OOS (out of specifications) reports and deviations.

- Coordinated clean room ops - sterilization validations, bioburden,

USP class testing, and VDmax testing.

. Supplier Quality System: Implemented SQS - in conjunction with

Purchasing - including audits (domestic and international, on site),

reports, qualifications, quality agreements, returns to vendors, and

score cards.

. Customer Validation: Supported customer validation-certification via

testing, agreements, and reviews. Assessed validation protocols - IQ,

OQ, PQ - for compliance, statistical validity and approval.

. Training: Conducted training in cGMP and Good Doc Practices for all

employees annually (around 40).

SONY MUSIC, Pitman NJ 2004-2007

Quality Process Engineer

Supervised 28 electro-mechanics technicians - across 4 production shifts -

in the CD-DVD replication area.

. Led Six Sigma Green Belt project: "DVD Area Yield Increment". Achieved

a yield increment from 89% to 92% during the season 2006, saving

$300K. Executed a DOE for parameter adjustment of DVD presses.

. Increased yield of CD lines from 88% to 95% via enforcement of new

SOPs (from prior six sigma project).

. Led Design, Development, and Roll Out of a supervisor dashboard that

eliminated manual data collection from all the replication areas on

all shifts. Dashboard showed Uptime, Downtime, and Status of DVD

machinery.

ADDITIONAL EXPERIENCE

DAIMLER CHRYSLER, Newark DE (2003) Maintenance Supervisor, Body in White

area as a contract through Aerotek

Supervised more than 45 Union Operators and 15 Union Skilled Technicians

simultaneously.

. Contributed to Black Belt project teams that addressed design issues,

collecting data and using Minitab software for statistical and

graphical analyses for the launch of the Durango 2004, this reduced

containment errors in 25%.

SUPERENVASES ENVALIC, Valencia, Venezuela (1995-2000): Project Manager in

beverage-packaging industry.

Led $7M initiative that doubled production capacity and improved overall

speed, technology and operation of the production line.

. Cut reprocess and scrap by 30% via improvement in lacquer supply,

which cut downtime of lacquer system.

. Improved Yield 25% via video inspectors. Cut overall costs 45% and

improved customer satisfaction.

VIDRIOLUX, Guacara, Venezuela (1994-1995): Electrical Maintenance

Supervisor for glass bottles for beverages.

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