Quality Assurance Control

Francisco J. Angel

Tel: 305-***-****/Cell: 347-***-****

E-mail: **********@*****.***

https://www.linkedin.com/in/francisco-angel-4a503761

Miami, FL 33165

OBJECTIVE:

To be an integral part of your organization’s success with my established professional skills and excellent work ethic.

KEY ACCOMPLISHMENTS:

Reformed the filing system and updated the inventory forms referring to the DEA registration numbers that led to a

successful audit by the FDA.

During the active research study, pointed out a major oversight that led to the correction and implementation that

save the company cost and met the completion of the study within its length of time.

SOFTWARE SKILLS:

Proficient in Microsoft Office

Suite-Applications

Manufacturing Execution Systems

(MES) -Application

JDE (Edwards) -Application

60-wpm (Typing)

Documentum-Application

Track Wise-Application

QuickBooks

Freelance Graphics

Windows NT/Windows 2000

Professional

EXPERIENCE:

SOURCEABILITY NORTH AMERICA LLC, Doral, FL

Quality Assurance Inspector Specialist (Temporary) 01/2016 – 03/2016

Inspected new and used electronic components for distribution.

Determined different types of electronic material’s quality and accurately interpret in notation.

Execute other tasks or projects as necessary.

Kelly Services/ KLX Aerospace, Doral, FL

Export Compliance Specialist/Product Integrity Administrator 06/2015 – 10/2015

(Contractor on-site)

Performed Quality Assurance tasks such as coordinating and analyzing to ensure that documentation applications of product restrictions and non-product restrictions are in accordance with the export-material requirements and regulations.

Defined different types of export classification codes to be suited to the proper product.

Interpreted the flow of material’s information and its existence development for distribution.

Worked effectively with cross-functional and globally dispersed teams.

eTeam Inc., Plainfield, NJ /Actavis/Watson, Inc., Miramar, FL

Quality Control Associate (Contractor on-site) 05/2014 – 04/2015

Implemented Quality Control functions such as verification, investigation, and to ensure clinical research procedures are in compliance with internal Protocols, SOPs, ICH Good Clinical Practices (ICH GCP), safety initiatives, and FDA regulations.

Verified written documentation from staff is accurate during the active-study-work.

Examined different types of documented process such as subject-admission, vitals intake, and injectable

formulation.

Informed management of obstacles and deviations from established internal and regulatory standards.

Francisco J. Angel

Noven Pharmaceuticals, Inc., Miami, FL

Quality Assurance Inspector I, 01/2013 – 02/2014

Complied with Quality Assurance procedures such as sampling, inspections, and test designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA, and DEA regulations.

Approved components in process operations through inspections.

Documented all work activities, including (QA-alerts) in the appropriate batch-records, forms, and logs to ensure

accuracy and compliance with cGMP, FDA, and DEA regulations.

Performed transactions in JD Edwards, TrackWise, and MES database when required.

Noven Pharmaceuticals, Inc. (Contractor on-site) Miami, FL 03/2008 – 12/2012

Documentation Specialist Assistant/Product Release Documentation Coordinator/Control Substance Assistant/ Quality Control Documentation Coordinator

Victoria & Associates (03/2008 -12/2011); The Staffing Resource Group-Life Sciences (02/2012 -12/2012)

Achieved status as in demand temp-worker for employment agencies within the Noven Pharmaceutical company throughout various departments as a support role.

Updated, proofread, and prepared documents such as Standard Operating Procedure.

Reviewed records to ensure that batch files are complete.

Ensured that Product Release specifications and SOPs binders are current.

Assisted Product Release’s Specialist in the entry of information on disposition labels and the printing of disposition

labels.

Typed and processed all changes submitted by Standard Test Procedure reviewers (Laboratory Analysts).

Tracked Changes and formatted documents to approve content from Document Control.

Maintained master templates of all Standard Test Procedures to be revised.

Initiated and monitored (Quality Records and Deviation Draft Records) within the Track Wise application database.

Interacted with Stakeholders for reviews, comments, and approvals in reference to the documentation process.

Edited and updated calculations within spreadsheets subject to mg and kg.

Assisted in the reformation of the filing system and updated the inventory forms referring to the DEA registration

numbers.

Supported audits and external inspections in different departments.

Distributed updated control documents (SOPs, Policies, STPs, and Specifications) to control binders and ensure

closure of document distribution.

Performed other duties and special projects as necessary.

EDUCATION:

Public Administration

Florida International University

(Near Completion)

Associate's Degree - Public Administration

Miami-Dade College

LANGUAGES:

Fluently in English and Spanish

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