Technical Support Quality

EDWIN JOSUE VILARO BREBAN

**** ***** ** ***** *.A 19124

787-***-**** / 787-***-**** *********@*******.***

Summary of Qualification

Dynamic professional in the Quality Assurances and Quality Control area with experiences in the pharmaceutical, medical devices and biotechnology industries. Capable to managing multiples tasks with a minimum supervision. Responsible, flexible and proven leadership skills. Teamwork oriented, self-started and fast leaned. Computer literate with knowledge in Word, Excel, Power Point, Outlook, laboratory system such as LIMS. Bilingual English and Spanish. I offer more than eight years of professional experience in the regulated industries for solid dosage and intravenous industries.

Working Experience

2012 – 2017 Baxter Healthcare – Jayuya, Puerto Rico

Chemist I

Project Deployment

Support Cali, Colombia Plant

Determine which situations were affecting GC, AA, and ICP-MS tests.

Reduce the time for Aluminum Testing from 12 days to 4 hours.

Assist and train staff in solving problems and troubleshooting on these equipment.

Assist in the transfer method for validation assay.

Check the facilities and recommend corrective actions for possible failures in the quality system.

Validation equipment’s (Agilent 7700X ICP’MS and Mileston Digestion Ultrawave);

Created test case for the IQ, OQ and PQ in the process validation.

Performed the assay validation transfer method for the elemental impurities.

I certified as Subject Manner Expert in a technique for Baxter research and bring support to other plants of Baxter Latino America for the validation equipment.

Perform testing for the Initial, Final, Raw Material and water cell; These included;

Released the testing on time for the raw materials and amino acid codes.

Bring support in the laboratory investigation, NCR and CAPA.

Bring support in other areas if necessary (Water and Initial).

Review the data in a notebooks, forms and calculation for the release batch.

Perform the 6’S in the Amino Acid room and ICP room.

2010 – 2012 McNeil LLC – Las Piedras, Puerto Rico

SAP Power User

Project Deployment

Participated in the compatibility assessment during initial phases of SAP R6 project in charge to ensure the application functionality and compliance. These included;

Performed workshops, presentation and training modules for the various areas of quality in the company.

Reviewed the quality procedures that were in a line with the SAP system.

Performed system tests to evaluate its overall functionality.

Responsible for the training sessions during R6 site project deployment.

Performed daily training sessions for new users of the application system.

Maintained and filed the training records for access to the system.

Provide technical support for users during first days in the initial implementation.

Responsible for Quality Department SAP support.

Assigned and updated status of in process and finished product lots within the SAP system.

Created and updated the inspection lots and inspection characteristic for evaluative processes.

Updated the incoming and stock quantities as required by daily operations.

Provide technical support for department clientele.

QA Technician

Performed QA audits and line clearances for the packaging line. These evaluations include impact assessment, as well as compliance of proposed mitigation strategies.

Responsible of reviewed the packaging line master batch record and the BOM. This execution also includes the corresponding verifications using the electronic inventory control system SAP and corrects issues for Quantic area.

Supplied the packaging components for the packaging line, ensuring compliance and operational continuity.

Assists on the initiation investigation for the NCR in the Quality area.

Over two years of compliant execution.

Knowledge and Skills

Training/Certification: Agilent 7700X ICP-MS, Train the trainer ICP-MS, Empower 3, Waters System Certification, SAP R6 Software Certification and Train the Trainer Certification

Laboratory programs: SAP, Lims, Poms, Empower, Winlab, MassHunter and other computer system.

Protocols executions: Precision, Accuracy, Linearity, Risk Assessment, Transfer Methods, DQ, IQ, OQ and PQ.

Created SOP’s, Forms, Logbooks and strategically tables.

Lean Manufacturing Techniques: Heijunka, Kanban, 5’s and others.

Pharmaceuticals Industries Regulations: USP, FDA, ISO and OSHA.

Knowledge and Troubleshooting in following equipment’s: ICP-MS, HPLC, UPLC, GC, FTIR, TOC, Dionex and Atomic Absorption (Aluminum, Calcium and Magnesium).

Short test; pH, color, heavy metals, iron, sulfate, and others.

Investigations: NCR, CAPA, OOS, OOL and related document for the investigation.

PC Literate.

Bilingual English & Spanish (Written & Oral).

Education

2003 – 2009 Interamerican University of Puerto Rico, Arecibo Campus

Bachelor Degree in Natural Sciences – Chemistry Major

2013 – 2015 Metropolitana University of Puerto Rico, Jayuya Campus

Master Degree in Management and Strategic Leadership

2015 – 2017 Metropolitana University of Puerto Rico, Jayuya Campus

Master Degree in Human Resources

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