Quality Assurance

Richard E. Ortiz

Urb. Santa Clara Calle Jaguas K-11 Guaynabo, PR 00969

Cel. 787-***-**** *********@*******.***

SUMMARY OF QUALIFICATIONS

Quality Compliance Auditor with over 15 years of experience within Pharmaceutical and

Medical Devices industries. Experience supervising a team of 20+ direct reports. Exceptional

problem solving skills. Vast experience performing internal and external audits, including ISO

9000 and ISO 140001 auditing in electronics, aerospace and pharmaceutical industries.

Knowledge of GMP’s, FDA, Local regulations and Six Sigma. Experience GMP trainer.

Computer literate. Bilingual in English and Spanish.

PROFESSIONAL EXPERIENCE

BIOVAIL LABORATORIES, Dorado, PR 2006 - 2009

QA Compliance Auditor

Trained employees on internal GMP and other company regulations.

Performed external audits to Suppliers and Contract Laboratory employees.

Responsible for investigating and analyzing material related to audits and prepared suppliers

corrective action plans.

Reviewed and approved manufacturing batch records.

Prepared monthly and quarterly presentations for the Quality Council Staff.

Responsible for reviewing and approving the development IQ, OQ and PQ validation

protocols and experimental studies.

In charge of all Quality Assurance technical writing.

Selected Accomplishments:

Selected to be responsible for the Document Retention Area which included highly

confidential and controlled information.

Successfully achieved a 100% employee GMP training participation by adding case

studies to the presentation and meeting with the leadership team to ensure all employees

were encouraged to participate.

IPR PHARMACEUTICALS, Canóvanas, PR 2004 – 2005

QAS Associate

Assigned Projects:

Quality and Compliance Manual - Responsible for maintenance and follow-up of the Quality &

Compliance Manual, and the Internal Audits throughout the iPR sites;Guayama, Carolina and

Canóvanas. In charge of reviewing vendors credential and compared them to company

requirements.

Informed affected areas about QCM's new and revised publications and reported the Key

Process Indicators monthly. Prepared the 2004 Quality & Compliance Report; former Letter of

Assurance.

Internal Audits - Performed 10 yearly plant audits in the established period. Reviewed

CAPA reports.

• Vendor Qualification Systems Representative - Reviewed of vendor requirements for ex-

recipients manufacturers. Performed external Audits to Vendors

Richard E. Ortiz Page 2

MANUFACTURING TECHNOLOGY SERVICES (MTS) Caguas, PR 2001-2004

QA Director

Responsible for giving support to companies such as: DCSI;Distribution Control System,

Emerson-White Rodgers, General Electric, Zoll Medical. and others. Provided support, trainings,

and generated quality procedures for MTS enterprises on Dominican Republic and Ireland. Acted

as Manufacturing Engineers for continuous product and process improvements. Coordinated the

transition, configuration, calibration, and manufacturing star-up activities for the quality systems

implementation for Repair, Storagetek among others. Performed quality audits, quality control

process charts, and defect analysis for DCSI products on the Dominican Republic. Directly

supervised 15 employees.

HAMILTON SUNDSTRAND OF PR, Santa Isabel, PR 1998– 2001

Quality Engineer & Supervisor

INTEL PUERTO RICO, Las Piedras, PR 1994 – 1998

Team Facilitator

UNITED STATES SURGICAL CORP., Ponce, PR 1991 – 1994

Quality Supervisor

EDUCATION

University of Puerto Rico, Mayagüez, PR

Technical degree in Electrical Engineering

University of Puerto Rico, Mayagüez, PR

Bachelors of Science in Biology

AFFILIATIONS

• Program Management Institute Member #1369483

• American Society for Quality; PR Chapter Member #00948041

Department of Education of PR Teachers License: 1090

Federal Aviation Agency Repairmen for Limited Accessories License: 2642910

Puerto Rico Basketball Referee Association

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