Rafael Rivera Morales(787) 768-1901 / (787) 603-2982 rafirm632003@yahoo.com

Summary of Qualifications

Licensed Chemist with extensive experience in Finished Product Laboratory specialized in analytical data reviewing processes of multiple products in the Pharmaceutical Industry. Focused on attention to details, Good Laboratory Practices environment (GLP’s), Current Good Manufacturing Practices (CGMP’s), company Standard Operating Procedures, applicable local, federal and company policies. Excellent analytical skills and perform analytical laboratory investigations. Computer literate in Microsoft Office, Lab Manager, Laboratory Information Management System (LIMS), Trackwise System and Peak Pro and Empower Chromatographic Systems. Fully bilingual English and Spanish.

Accomplishments

Cycle time Reduction in Finished Product Laboratory. Increase of KEY Products Approval. Templates creation for Raw Material, Finished Product and Microbiology Laboratories in LIMS to

enhance the agility of laboratories to report and generates reports electronically. Colleague Engagement Certificate of Appreciation

Professional Experience

Pfizer Pharmaceuticals, LLC., Vega Baja, Puerto RicoLaboratory Analyst 2011 – 2013

Participated in audits to analytical laboratory procedures and laboratory processes. Trained as Laboratory Information Management System (LIMS) Template Builder by IT Personnel

due to change in business needs. Managed the creation of Analytical Templates for Finished Product Laboratory. Updated existing Finished Product, Raw Material and Microbiology templates in LIMS according

to Analytical Procedures, Policies and Current Compendia procedures. Provided training to temporary laboratory colleague as LIMS Back-Up Template Builder. Facilitated training to other laboratory colleagues to perform the finished product and Raw

Material Laboratory sample logging in LIMS. Updated and Improved the Raw Material, Microbiology and Finished Product LIMS Laboratory

Templates during the SAP – SQL*LIMS Interface project implementation from June 2013 to November 2013.

Collaborated with the Product Transfer and Products Validation from different sites to Vega Baja site.

Warner Lambert, PDPL and Pfizer Pharmaceuticals, LLC Vega Baja, Puerto RicoLaboratory Analyst 1998 – 2011

Coordinated laboratory daily and monthly tasks as well as preparation of weekly Finished Product Analyst Testing Schedule.

Reviewed and approved data related to the analytical testing ensuring compliance to requirements set forth in applicable standards and test methods.

Conducted Analytical Laboratory Investigations for Questionable results, Out of Specification and Out of Trend results.

Provided training to new personnel and existing on analytical testing and proper testing techniques.

Monitored and performed regularly audits of existing Finished Product Analytical Procedures. Collected documentation to prepare and submit a Product Change Request (PCR’s).

Rafael Rivera Morales Page 2

Laboratory Analyst 1994 – 1998

Provided support to Stability Area to enter the Stability Results electronically using the Science Software.

Performed Statistical Linear regression per stability analytical testing for each Stability Study to monitor the product tendency until expiration date testing period.

Open New Stability Study and Close all Stability Studies that reach the expiration date period following company procedures.

Prepared the Annual Product Report to CMC to submit the results of lots in the Company Stability Program.

Raw Material, Finished Product and Stability Laboratory Analyst 1988 – 1994

Performed analytical testing using qualified laboratory equipment and procedures applicable to the department for Finished Product and Stability Laboratories.

Reviewed Data of Analytical Testing performed by other Laboratory Colleagues. Informed to Laboratory Supervisor / Team Leader for Out of Specification results. Performed Laboratory Linear Regression to qualify the Analytical equipment to be used before

perform the test.

Education

University of Puerto Rico Rio Piedras CampusBS Chemistry

Licensed Chemist #3050

Trainings

Human Error Reduction Current Good Manufacturing Practices (CGMP’s) Code of Federal Regulations (CFR) Current Good Laboratory Practices (CGLP’s) Train the Trainers Excel 2007: Beyond the Basics Raman Spectroscopy Peak Pro and Empower Chromatographic Data System RCRA Training Requirements

Affiliations

Active Member of Colegio De Químicos de Puerto Rico