Profile Twenty-plus years of experience as quality professional for the

regulated industry (pharmaceutical, biotechnology, medical

devices, food & beverage)

Environmental Research Assistant (Univ. of Turabo, School of

Science and Technology)

Export Research Assistant (Univ. of Turabo, School of Business

& Entrepreneurship)

Lecturer for the MBA evening program at Sistema Ana G. M ndez

(Univ. of Turabo)

Author of academic article published on refereed journal:

Navedo-Samper, T., Ferrer, E. Rivera-Ruiz, I. (2013) Moderating

Effects of Human Factors on IT-Business and IT Effectiveness on

Modern Firms. Journal of Knowledge Management, Economics and

Information Technology, 3(2).

Education DBA candidate (Management) (2009-2015), Univ. of Turabo, School

of Business and Entrepreneurship

MBA (Management) (2009), Univ. of Turabo, School of Business

and Entrepreneurship

Bachelor Degree in Chemistry (1988), Univ. of Puerto Rico,

Natural Sciences Department

15 approved credits toward a Ph.D. (Environmental Chemistry)

(2010-2011), Univ. of Turabo, School of Sciences and Technology

Proficienc Full experience in Quality Systems, Computer System Validation

y (CSV), writing skills for qualification deliverables (VP, URS,

FD, TM, RA, IOQ, PQ, SOP, VSR), execution and reporting /

Material Review Board (MRB) Coordinator / Quality Auditor /

Chemistry / Research on Business Scenarios / Marketing / Global

Strategic Sourcing / Chemical Hygiene Officer / Bilingual

skills / Computer Literate (Word, Excel, PowerPoint, SPSS) /

Industry practices (cGMP, GLP) / Federal Regulations (21CFR

Part210 & 211, 21CFR Part11, FDA, OSHA and DOT)

Trainings 2006 Six Sigma Green Belt Academia (48.0 hrs.) Business

Excellence Consulting

2002 Basic Training in Programmable Logic Controllers

(PLC) (30.0 hrs.) Mech-Tech College

1997 Design of Experiment Academia (24.0 hrs.) ASQ

1996 Quality Engineering Academia (48.0 hrs.) ASQ

1994 Master and Capacity Requirement Planning Course APICS

(American Production and Inventory Control Society)

1992 Quality Auditor Academia (40.0 hrs.) ASQ

Employmen Computer System Validation Consultant (Several 2000-Prese

t consulting firms) nt

Assure the suitability (consistent and reliable

performance to all defined requirements) and

compliance with 21Part 11 regulations, of

analytical laboratory systems and laboratory

equipment, in the pharmaceutical, medical

devices, and biotechnology industry.

Development of qualification deliverables,

execution and reporting.

Lecturer / Export Research Assistant (3ary 2012-2014

Education - Private Institution)

MBA program evening lecturer (Course:

Organizational Behavior)

Research and analysis of business scenarios in

Central and South America to instruct and

potentiate the local Small and Medium Enterprises

(SME's) exporting possibilities.

Environmental Research Assistant (3ary Education Summer

- Private Institution) 2010

Synthesis and characterization of porous

materials (Prussian Blue analogues and

Nitroprussides) for pollution control. Research

Instrumentation: TGA, FTIR, Physic-sorption

analyzer.

Pharmaceutical Sales Representative 1999-2000

(Pharmaceutical Industry)

Administration of an assigned territory

(marketing of controlled medications to

healthcare representatives).

Material Review Board Coordinator (MRB) / 1991-1999

Operation Support Specialist / Chemist (Food &

Beverage Industry)

Directing investigations on corrective

action-preventive action (CAPA) about potential

and observable discrepant conditions, for the

prevention and/or mitigation of material losses.

Developing and executing investigations about

productivity improvements and cost reduction, for

laboratory operations and manufacturing processes

Reporting findings and conclusions to the

management audience.

Global Strategic Procurement Representative / 1990-1991

Chemical Hygiene Officer / Chemist (Medical

Devices Industry)

Managing a supply chain that included the

procurement of raw material, from international

and domestic sources, and quality assurance

through analytical procedures.

Advising on initiatives that encouraged

environmental, health, and safety conditions,

monitored working environments to identify root

causes and prevent the risk of accidents in the

working place.

Chemist / Quality Audit Team Member 1988-1990

(Pharmaceutical Industry)

Analyzing raw material, packaging components, and

finished products in QA Lab.

Inspecting, verifying and assuring that

laboratory components (equipment, instrument, raw

material, record keeping, personnel

qualification, environment conditions) were in

compliance with regulations, procedures and

internal guidelines.

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