Amy Santiago

 

Caguas Tower Apt. 1807 – Caguas, Puerto Rico 00725 – Tel. 787-743-2841

 

Objective

 

Seeking a challenging position in the area of Quality Assurance or Warehousing that can maximize my past experience.

 

Background Summary

 

Extensive Pharmaceutical Industry experience in the areas of Quality Assurance as a Product Release Expeditor and in Warehousing.  Considered to be a very reliable, organized, motivated and goal oriented professional who learns new functions fast and establishes excellent working relations within the function and with other departments.  Excellent knowledge of Product Release, QA SOPs, GMPs, AS/400 System, EMBR System, QIS and MAS-E Systems.  Excellent communications skills in verbal and written form in English and Spanish.  Computer literate in Microsoft Office software.

 

Work History

 

Cardinal Health Manufacturing Services, Inc. – Humacao, PR              2000 – 2001

(Formerly Alcon Puerto Rico, Inc.)

Product Release Expeditor

Assures that Manufacturing Batch Records (MBRs) are properly documented and reviewed to determine compliance with established written procedures before disposition.  Reviews lot records for final disposition.  Coordinates correction of errors and deviations with the manufacturing department.  Compile Lab., STAs, and Spores reports for final disposition.

 

Alcon Puerto Rico, Inc. – Humacao, PR                                                     1984 – 2000

Product Release Expeditor (Same as Above)                                               1994 – 2000

Product Release Specialist                                                                            1989 – 1994

QA Product Line Inspector                                                                             1984 – 1989

 

Early Experience

Carnation Milk Products Co. – Houston, Tx. – Loadout Supervisor

Warner Lambert, Inc. – Fajardo, PR -  Warehouse Supervisor

 

Accomplishments

 

¨       Recognized as Symbol Worker of the Quality Control/Assurance Department by organization’s top management.

¨       A documentation system was not available to document final product disposition.  Developed a spreadsheet to document process including determining and coordinating target dates for release.  This helped to establish and follow priorities and ensured product release on a timely basis for shipping purposes.

¨       During my experience as an Expeditor the Company was never assessed any penalties or 483 observations during FDA inspections related to product and process documentation.

 

Education

 

Interamerican University – Fajardo, PR

72 Credits approved toward BA Degree – Management Concentration