Angel M Rodriguez

Wawa, Inc

Jul 2012 to 2000
Fresh Food Manager
The Restaurant School at Walnut Hill College
Philadelphia, PA
Oct 2011 to Jul 2012
Fellowship/Sous Chef
Radisson Convention Center
King of Prussia, PA
Apr 2011 to Oct 2011
Intern Line/Prep Cook

The Restaurant School at Walnut Hill College
Philadelphia, PA
Sep 2008 to Jul 2011
Bachelor of Science in Culinary Arts

Culinary Management

Office of Municipal Emergency Management
Ponce, PR
Jul 2010 to Jan 2015
Emergency Medical Technician
Office of Municipal Emergency Management
Ponce, PR
Apr 2014 to Dec 2014
Emergency Medical Services Educator/Professor
Advanced Paramedic Services
Yauco, PR, US
Feb 2009 to Sep 2010
Emergency Medical Technician- Supervisor
Castillo Life Support Ambulance
Ponce, PR
Sep 2007 to Feb 2009
Emergency Medical Technician
Continental Airlines
Newark, NJ
Jan 2007 to Sep 2007
Ramp Agent
Wegman's Grocers
Mount Laurel, NJ
Jun 2006 to Nov 2006
Customer Service Representative

Ponce Paramedical College
Ponce, PR
2001
Vocational in Medical Services/EMT

SEC Group
Philadelphia, PA
Jan 2015 to Feb 2015
Assistant Manager/Sales
Disston chiropractic
Philadelphia, PA
Nov 2013 to Dec 2014
Medical biller/receptionist
Home depot
Philadelphia, PA
Jan 2014 to Jun 2014
Cashier/Sales Associate

Everest institute
Philadelphia, PA
2013 to 2014
Certification in Medical Insurance billing and coding specialist

U.P.S
Philadelphia, PA
2014 to Dec 2014
Driver Helper
JCW Computer Consulting, LLC
Philadelphia, PA
Mar 2014 to May 2014
Computer Repair Technician
Non Profit Technology Resource
Philadelphia, PA
2012 to 2012
Computer Support Intern

Metropolitan Career Center CTI
Philadelphia, PA
2010 to 2012
Associate's in Information Technology

Computer Hardware, Network Technology, HTML, Visual Basic, SQL, Google Apps for Business, CRM App Insightly!, Windows XP to 7 Migration.

JBS
Souderton, PA
Jun 2011 to Jan 2012
Fabrication Department of Meat
Dunkin Donuts
Bronx, NY
Apr 2010 to Jul 2010
Morning Preparer
Dunkin Donuts
Tampa, FL
May 2009 to Sep 2009
Night closer
Sonic Drive-in
Tampa, FL
Oct 2008 to May 2009
Cooker

Instituto de Banca y Comercio
Patillas, PR, US
2000
High School Diploma

All American Limo Company
Philadelphia, PA
Jan 1996 to Jul 2013
Detailer

Edison High School
Philadelphia, PA
1998 to 2001
N/A in N/A

Cariola Group

Jan 2013 to 2000
HR Coordinator
Wells Fargo Bank
Saddle Brook, NJ
Oct 1999 to Dec 2010
Personal Banker
United States Army Reserves
Fort Dix, NJ
Aug 1995 to Jul 2003
Military Police Officer
North American Van Lines
Paramus, NJ
Mar 1997 to Oct 1999
Logistics Customer Service Representative

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.