Quality Assurance Manager

Yasily Ogando Roa

*** ******** *****, **** ******, NY 11554

Phone: 516-***-**** E-mail: ************@*****.***

Objective:

To obtain a position in Quality Assurance in a company that requires expertise in the Pharmaceutical field areas including other processes like ISO, FDA CFR820, GMP’s, GLP’s and TQM. More than 20 years of experience in Quality Assurance. Knowledge in Inspections, raw material, finished good, product specifications, product disposition, customer complaints, CAPA, certificate of analysis, and internal and external audits.

Professional Experience:

January 2009 –March 2012

Quality Assurance Manager-– Post Consumer Recycling PET Company. Pure Tech Plastics, Nassau, NY

• Responsible to create (from scratch), develop, maintain and control all aspects of Quality system that continually improves the Quality Management System.

• Develop, review, and implement quality policies, quality plan, procedures, internal process parameters in accordance with the customer’s requirements, standards, and in compliance with the FDA Non-Objections Letter base on CFR21 and CTS83498.

• Quality Lab Management, evaluating lab product results, record keeping, process parameters (SPC) in order to meet customer specifications.

• Pure Tech Finished Goods Inventory Manager and Customer Load Building Pure Tech & 3rd Party (Release Final Product).

• Manage Internal Audit Program, GMP’s and hygiene Audits, 3rd Party Audit, FDA and Safety Audit as well.

• Safety Officer, and Safety Committee Chairman

• Management Representative (Customer Communications)

• Manage Corrective actions, investigates Root Cause Analysis, formulate and issue 8D Reports and Suppliers Quality Alerts.

• Management Review meeting coordinator.

• Document control, plant standards, Continuous improvement program, and plan training requirements for the manufacturing plant.

August 2007 – January 2009

Quality Engineer – Metal Stamping Company. Johnson & Hoffman, Nassau, NY

• Maintain and analyze SPC data

• ISO 9001:2000 and TS16949 Internal auditor

• Document and data control

• APQP meetings

• Issue and update PPAPs.

• Initiate and track corrective actions, 8D Reports and CA Verifications.

• In-process & ISIR sheet preparation and review.

• Internal Auditor

• Quality Assurance Department Supervisor

• Receiving Inspection of Raw Material

October 2003 – August 2007

Quality Engineer – Brainin Advanced. Attleboro, MA

• Maintain and analyze SPC data.

• Prepare and maintain Documented Procedures, and Work Instructions

• ISO 9001:2000 and TS16949 Internal auditor

• Document and data control

• Monthly Objective Report

• Monthly Customer Rating Report

• Reviews PPAPs.

• Initiate and track corrective actions, 8D Reports and CA Verifications.

• In-process sheet preparation and review.

• Gage R & R studies.

• Quality System Coordinator - Patton Macguyer, Inc (This Company was bought by Brainin Advanced in 2005). Providence RI

• Responsible to maintain and control all aspects of Quality system that continually improves the Quality Management System in accordance with the requirements of ISO 9001: 2000. Responsible to coordinate and follow up the MRB meeting, issued and maintains the NCMR system, the Corrective system and the Preventive Action System. Responsible for the external and internal audit programs.

January 1996 – December 2002 Corporate Quality Assurance Manager Polyplas, Santo Domingo, Dominican Republic. (PET, HDPE, LDPE, Polycarbonate,

PVC and PP).

• Developed (from scratch), implemented, and monitored a Quality Assurance Management System for different manufacturing plastic process systems (Injection, Extrusion, and blow Molding). Responsible to maintain and control all aspects of Quality system that continually improves the Quality Management System in accordance with the requirements of ISO 9001: 2000.

• Coordinate and follow up all Customers Complaints meeting.

• External and internal audit programs.

January 1992 – January 1996 GMP Officer/Quality Assurance Lead Auditor - Abbott Hospital (Intravenous Medical Devices Division), San Cristobal, Dominican Republic.

• Assure FDA CFR21 compliance and Corporate Abbott Guidelines were followed.

• Lead Auditor responsible for the Internal Audits Program per FDA CFR21. Coordinate the Audit and issue the corrective actions of any nonconformities found.

• Chairman of weekly Quality Staff meetings to discuss TQM.

• Customer complaints, implement Corrective Actions, and verified corrective action effectiveness.

• Validate and certify the production lines according to STD209E Environmental Contamination Control to comply with a production floor class 100.

• Validate and certify the sterilization room according to Cobalt 60 Gamma Food Irradiation FDA for Intravenous sets. Verifying and Confirm that the sterilization room adhere to the specification before releasing the product for human consumption.

• Keep and follow up any new FDA and the corporate requirements that need to be implemented in the production plant.

Education:

• BA Degree in Computer and Systems - Universidad Dominicana 0 & M, Santo Domingo, Dominican Republic - June 1990

• Quality Engineering Degree - Intec: Quality Council of Puerto Rico – August 1998

• Actually taking preparations for the Certified Manager of Quality Organizational Excellence Certification by ASQC (CQM/OE).

Certifications/Skills

•System Process Control (SPC)

•Total Quality System Design

ISO 13485 (21 CFR part 820) Medical Devices

•Internal Auditor Base on ISO 9001:2000

.ISO/TS 16949:2002 Auditor – Caliso

•Good Manufacturing Practices - ABBOTT

•English as Second Language, RI University

•Goal Setting Workshop- ABBOTT: HPD Resources

•Human Relationship and Team Work.

•PPAP 4th. AIAG Webinar – Brainin

•Optical Measurements – Brainin

•Print Reading – Brainin

.KAIZEN – Continuous Improvement – Autoliv

.5-S Program – Autoliv

.IMDS Systems – Autoliv

Microsoft Office: Windows, Word, Excel, Microsoft Power Point, Microsoft Access, and Minitab.

Bilingual: Fluent written and verbal Spanish and English.

Contact this candidate