Angel C Rodriguez

Heil Trailer International

Jun 2012 to 2000
Welder/Fabricator
JcPenney Logistics
Haslet, TX
May 2008 to Apr 2012
Merchandise Stock Associate
Wood Brothers Saw Company
Haslet, TX
Jan 2004 to Oct 2007
Machine Operator

Northwest ISD
Justin, TX
General Equivalency Diploma

Bilingual, Strong communication skills, Goal-oriented, Capable of working in fast paced environment, Lean Bronze Certification thru Heil Trailer International

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.

OneExchange
Richardson, TX
Jun 2013 to Dec 2014
Sr Benefit Advisor
Sonic
Abilene, TX
Jul 2012 to Nov 2014
Carhop
Sunridge Property Management

1997 to 2010
Accounting Clerk
H&R Block
Mesquite, TX
1997 to 1997
Tax Preparer
H&R Block
Mesquite, TX
1996 to 1996
Tax Preparer

Garland High School
Insurance

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

Dollar General

2011 to 2000
Store Associate
Farmersbranch, TX

1997 to 2010
Accounting Clerk
H&R Block
Mesquite, TX
1997 to 1997
Tax Preparation, Data entry, Phones, 10-Key, Typing and Customer Service
H&R Block
Mesquite, TX
1996 to 1996
Tax Preparation, Data entry, Phones, 10-Key, Typing and Customer Service

Garland High School
TX Dept Of Insurance

North American Logistics (nalSyncreon)
Plano, TX
Sep 2001 to Sep 2011
Lead Logistics Program Coordinator Supervisor
Covad Communications
Irving, TX
Jul 2000 to Aug 2001
Logistics Manager
Sealand Service, Inc
Dallas, TX
May 1992 to Jul 2000
Intermodal Logistics Operations Team Lead
Hallmark Electronics
Dallas, TX
May 1991 to May 1992
Customer Service Representative

University of Phoenix
Dallas, TX
Aug 2007 to Jun 2009
business management
Brookhaven College
Dallas, TX
Aug 1993 to May 1994
business management
Richland College
Dallas, TX
Jan 1991 to Jun 1991
business management
Bishop Lynch High School
Dallas, TX
Sep 1986 to May 1990