Orlando Suero

*** ****** **. *********, ** ***** (C) 732-***-**** orlandosuero63@gmail .com

PROFESSIONAL SUMMARY

Dedicated, detail-oriented professional with 25+ years of Quality Assurance / Quality Control experience within the pharmaceutical, medical device manufacturing environment. Proficient in a number of related Manufacturing/ Productions processes supporting Regulatory / Quality compliancy. Maintaining systems, procedures, policies, monitoring projects and creating databases supporting overall process improvement initiatives and cost effectiveness measures. Determined to implement earned skills and willing to accept new challenges.

SKILLS

Knowledge of FDA Regulations, ISO 13485, 9001, Safe Quality Foods (SQF) and HACCP guidelines.

Pharmaceutical (OTC, Controlled Drugs Class I, II) Orthopedic Implant, Defense contract experienced.

Knowledge of pharmaceutical OTC and food aseptic / sterile packaging technics.

Knowledge of six Sigma Lean Manufacturing methodologies.

20+ year experience with change control, document, management.

Knowledge of equipment and system process validation via statistical analysis.

Experience with writing and executing CAPAs with current method or system being utilized to document and track internal / external non-conformances.

Strong interface with Customer and Auditors.

Lead team for new and existing critical supplier audit / qualification activities.

Lead meetings involving supplier Quality audits related issues.

Provide leadership to analyze, identify, quantify and measure specific quality initiatives specifically for audit and quality assurance, so product output meets company specifications and client expectations.

Machine manufacturing experience involving rare metal fabrication and plastic and rubber injection molding in addition to hydroforming, CNC / milling of low tolerance manufactured parts for the defense and aviation industry.

Knowledge of Geometric Dimensioning and Tolerance (GD&T)

Understanding of high tolerance blue print schematics.

Electronic equipment testing experience.

Advanced skill with all MS Office programs.

STRENGTHS

Highly adaptable, self- motivated with a strong attention to details and organization..

Strong interpersonal skills and leadership exhibiting confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; gives appropriate recognition to others.

Customer Service-Responds promptly to customer needs and responds to request for service and assistance; meets commitments.

Analytical- Experience in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions in a timely manner. Synthesize complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs workflows and procedures. Maintain attention to detail.

WORK HISTORY

IT Project Quality Compliance Manager 12/2016 to 06/2017 ALCON /NOVARTIS Pharmaceutical – FT. WORTH, TEXAS

Responsible for the assessment, facilitation and verification of quality standards achieved within IT projects activities in accordance with Novartis corporate requirements to ensure that the quality of processes and deliverables of both projects and services continuously meet their specified corporate and regulatory requirements.

Quality Assurance Manager 05/2015 to 12/2016

WESTROCK CORPORATION – WAXAHACHIE, TX

Manage all aspects of plant quality systems, including document control, deviations, CAPA, supplier quality, change control, quality assurance, finished product review and release.

Oversee manufacturing process meets implemented cost effective measures relevant to Quality.

Direct Customer Service support and communications by coordinating all aspects product Quality related issues. Domestic as well as foreign travel required.

Manage all aspects of plant quality systems, including document control, deviations, CAPA, supplier quality, change control, quality assurance, finished product review and release.

Responsible for testing the systems used to develop or manufacture new products launch through standard validation process.

Quality Engineer 12/2011 to 06/2013

WEST-WARD PHARMACEUTICAL- EATONTOWN, NJ

Integral part of the organization steering committee providing remediation support to address FDA findings.

FMEA (Failure Mode and Effects Analysis), data analysis and problem solving techniques.

Assist in the development and implementation of standard approaches to data analysis and statistical control techniques (SPC / SQC) supporting FDA submission for new product launch. Mechanical QC Supervisor 10/2006 to 10/2010

INTERNATIONAL TECHNIDYNE CORP- EDISON, NJ

Monitoring manufacturing and Quality performance of product, equipment.

Supported Quality engineering utilizing PPAP / FMEA technics for new product development.

Troubleshoot returned Electronic equipment for Quality issues and test failures.

Overall cost effective measures utilizing both Six Sigma and Lean Manufacturing techniques.

Direct customer communication and management of returned failed electronic equipment due to Quality issues.

Lead Quality –PLASTIC/ RUBBER INJECTION MOLDING MFR. 8/2000 to 10/2002 Polymer Technologies Inc. - Clifton, NJ

Manufacturing Operator/ Quality – Precision Metal Mfr. 10/1987 to 10/1994 C.B KAUPP & SONS- MAPLEWOOD, NJ

Supported Quality engineering utilizing PPAP / FMEA technics for new product development. EDUCATION

Associated degree Hotel / Restaurant Management. Fairleigh Dickinson U. Rutherford, NJ 1984-1986

Customer Service /Hospitality 1984-1986

Human Relations Santo Domingo Dominican Rep. 1981-1982 LANGUAGES

Bi-lingual, fluent in Spanish both written and reading SPECIALIZED SKILLS

Safe Quality Food (SQF ) HACCP Certified

Geometric Dimension & Tolerance (GD&T) Certified

Manufacturing Six Sigma / Lean Mfg. experience.

Supplier audit /qualification experienced.

CAPA / Validation / FMEA experienced.

Novartis ICE, Agile methodology certified.

Pilgrim / Oracle / JDE Software System

Experienced with Smart-Scope visual measuring equipment.

CMM operator experience.

Experienced with electronic inventory system SAP and JD Edwards.

Computer Literate - WIN 2010, Word, Excel, LIMS,CALS. PowerPoint and Internet.

Sales (Account Management) and Human Resources & Customer Service experienced. SOCIAL NETWORK

Please visit my LinkedIn profile for complete career experience and work history details at; https://www.linkedin.com/in/orlando-suero-a52b2226/ A list of work references, letters of recommendations and certifications available upon request.

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