Angel J Rodriguez

Spiceworks Inc

2014 to 2014
Software Development Intern

Cornell University
2011 to 2015
B.A. in Computer Science

Gypsy Cafe
San Antonio, TX
Sep 2012 to Jun 2014
Server/Cook/ Team Leader
Subway
El Paso, TX
Jan 2012 to Jul 2012
Sandwich Artist

El Paso Academy East
El Paso, TX
2008 to 2011
High School Diploma in All in General

Self Employed

Feb 2009 to 2000
INDEPENDENT REGULATORY SCIENCE CONSULTANT
KV PHARMACEUTICAL COMPANY
St. Louis, MO
Jul 1999 to Feb 2009
Regulatory Affairs Director

University of Puerto Rico
Mayagez, PR
1981 to 1985
BSc in Chemistry

Regulatory Affairs Preparation and review of ANDAs, NDAs, INDs, DMFs, amendments, supplements, annual reports, state licensing, product listing, facility registration. Familiar with e-CTD format including preparation and review of Quality Overall Summary. Direct interaction with FDA (Office of immunologic and anti-infective, office of generic drugs). European regulatory requirements. Latin America and Canada submission experience. Regulatory Strategic Assessment. Regulatory intelligence. Technical/Regulatory/Medical Writer - Hands on experience writing/editing manufacturing batch records, analytical methods, validation protocols/reports, stability protocol/reports, expert reports, product development reports, clinical protocols, clinical final reports, periodic safety reports. Labeling - Target product profile, initial and post approval, maintenance, international, promotional, advertising Experienced Manager Training. Oversight and follow up of activities. Performance coaching / appraisal. Staffing. Project management. Analytical Chemistry Chromatography. Spectrophotometry. Dissolution. Wet chemistry. Development and validation of analytical methods. Preparation and review of stability reports. Quality Operations cGMPs. Audits (master batch records, analytical raw data). Out of specification investigations. Non-conformance reports. Process deviation assessment. Change control procedures. Standard operating procedures. CAPA. Exception reports. FDA inspection management (principal escort and support group). Annual reviews. Manufacturing Operations Granulation (fluid bed, spray dried, high / low shear, direct compaction, extrusion / spheronization). Coating (beads, tablets). Blending. Unit dosing (compression / encapsulation / soft gel capsules). Oral liquids. Suspensions. Sterile (small volume parenterals, emulsions). Powders (for reconstitution, topicals). Semisolids (creams, ointments, gels, patches). Packaging Operations Qualification of container / closure systems. Oversight of packaging operations (solids, liquids and semisolids). Technical Services Generation, execution and review of process validation, IQ, OQ and PQ protocols. Process optimization / trouble shooting. Technology transfer (from R&D to production). Generation of master batch records, analytical methods, specifications. Product Development Reverse engineering. Formula and process design. IIG. Quality overall summary. Product development reports. Establishment of specifications. Qualification of raw materials. Strategic Assessment Due diligence. Product evaluation (technical, regulatory). International submissions. Intellectual property (evaluation of prior art, patent disclosures, development of paragraph IV strategies). Internet based research. Clinical Development Preliminary design of clinical trials (type of studies, clinical end points, patient population). Clinical study audits. CRO selection process. Evaluation of bio lab procedures. Language Fully bilingual (Spanish English). Can read and translate documents from Portuguese.

Jose Corena

May 2011 to Present
Community Volunteer Work
Dr. Shigeru Takehana D.D.S
Montebello, CA
Jun 2010 to Mar 2011
Dental Assistant
Allied Office Systems
Santa Fe Springs, CA
May 2007 to Nov 2009
Mover Installer

Rio Hondo College
Whittier, CA
Psychology
Everest College
Industry, CA
Sep 2009 to Jun 2010
Diploma

MEDICAL SURGICAL
Aventura, FL
Apr 2012 to Aug 2013
Registered Nurse
VALET WASTE, INC
Tampa, FL
Jun 2006 to Jan 2012
Regional Manager, South East Florida
DMI IMPORTS
Pompano Beach, FL
2004 to 2006
Operations Manager
MOTOROLA, INC
Plantation, FL
1993 to 2003
Technical Production/Material Supervisor

Army Reserve (83rd MP Co.)

May 2013 to 2000
Sergeant
Valero Corner Store

Apr 2013 to 2000
Customer Service Representative
Clinical Pathology Laboratories

Oct 2012 to 2000
Courier
Contemporary Services Corporation

Aug 2012 to 2000
Event Staff
US Army (active)
El Paso, TX
Aug 2008 to Aug 2012
Sergeant/Team Leader

Auburn High School
Auburn, WA
2003 to 2007
HS Diploma and 14 college credits

Rank: Sergeant (E-5) Dec 2007 to 2000
Branch: US ArmyL.i.location.original

Cal Fire
Susanville, CA
Feb 2010 to Jun 2012
Inmate Hand Crew
First Saw
Wilmington, CA
Jun 2008 to Nov 2008
Pile Driver
Bethel Church San Gabriel
San Gabriel, CA
Mar 2008 to Jun 2008
Volunteer construction, framing and drywall
Vanguard Steel Construction
Montclair, CA
Jan 1997 to Feb 1998
Construction Laborer

Chaffey College
Fontana, CA
Nov 2007
Construction Trades

Appliance Smart
San Antonio, TX
Sep 2012 to Dec 2012
warehouse worker
Americold
San Antonio, TX
Mar 2012 to Jul 2012
warehouse Worker/Forklift Operater
FIESTA WAREHOUSING
San Antonio, TX
May 2008 to Mar 2012
Supervisor
Takumi
San Antonio, TX
Apr 2007 to Jul 2007
Material handler
DOLLAR GENERAL
San Antonio, TX
May 2006 to Apr 2007
assistant manager
Target
San Antonio, TX
Mar 2002 to Dec 2006
retail product stocker
POLO LOCO
San Antonio, TX
May 2002 to Jul 2002
COOK
DELICIOUS TAMALES
San Antonio, TX
Feb 2001 to Feb 2002
Assistant Manager
AARON
San Antonio, TX
Nov 1999 to Jan 2001
DELIVERY DRIVER
BANK OF AMERICA
Los Angeles, CA
Feb 1989 to Jul 1997
CLERICAL SPECIALIST/MACHINE SPECIALIST

Supervisory,management,Forklif... operator,trainer,customer service.