Quality Engineer Customer Service

SUMMARY OF QUALIFICATIONS

Over fourteen (**) years of diversified experience in FDA biotechnology, pharmaceutical, medical devices and combination manufacturing facilities. Strong quality systems management and LEAN mfg professional, particularly effective in quality control/assurance areas. Within the site and supplier quality roles, generated, presented and implemented Quality Systems Management Reviews, business reviews, field actions proposals, escalated to product quality review board chaired by the Enterprise and Franchise VPs. As a chairman to the global supplier management board, monitored all mayor quality, compliance and procurement systems to identify risk areas and opportunities to key supplier partnerships. Managed the site and supplier Quality/Technical agreements program for all the supplier base and customers through many global markets at a Franchise level. Critical to quality parameters monitoring through KPIs implementation. Led CTQs specification generation from blue prints evaluation, validations review and cross-functional discussion. As an ISO 13485, 9001 and CFR certified Lead Auditor, performed audits and Supplier Assessments to domestic and international suppliers. Performed APRs Reviews and Approval for thoroughness and, completeness in order to guarantee suitability of Quality Systems implementation, challenge product impact, disposition assessments conclusions, and corrective/preventive actions, as needed to comply with CFRs. Commended with several company awards due to performance and achievement, by modeling key success behavior. Excellent team player in challenging environments. Applied technical skills and always willing to learn and develop. Hard worker customer service oriented. Demonstrated personal and business company values. Strong commitment with the patient health and compliance mindset.

PROFESSIONAL EXPERIENCE

07/2013 – Present Smith & Nephew Biotherapeutics Curaçao, N.V.

Quality Systems (CAPA) Manager

As an expatriated professional, formalized the Quality Management Systems for an enzyme based biologic ointment processes in aseptic conditions by identifying areas of regulatory compliance risks within the QMS for plan creation, proposal and implementation in order to mitigate regulatory risks.

Integrated the support for the deviations and CAPAs backlog reduction activities through a holistic collaboration of the functional areas and built a preemptive response of their managers to avoid unnecessary records generation.

Supported a manufacturing volume increase while meeting budget constraints.

04/2011 – 07/2013 Ortho Clinical Diagnostics Raritan, NJ

Supplier Quality Engineer II

Direct back-up to the World Wide Director of Supplier Quality Management for Multiple Franchise clusters.

Provided quality direction and oversight to key supplier’s Quality Management Systems, mostly interacting with their site investigation and CAPA systems.

Implemented an improved site supplier management program in support of a global program roll out, to reduce supplier related field actions with the objective to increase customer safety, satisfaction and supplier partnership.

Managed roadblocks towards completion of legacy CAPAs and mitigated the system compliance risks by implementing a new system to avoid overdue CAPAs.

05/2010 – 04/2011 Redelements Corporation Caguas, PR

Project Manager

As a contracted consultant, implemented and provided feedback of a global Supplier Review Board, for the procurement organization of the pharmaceutical industry.

Lead the implementation of a standard for all types of supplier on-boarding requirements and screening.

Assessed the organization CAPA system for areas of opportunities. Improved the CAPA effectiveness system by modifying the documentation requirements and practices.

05/2007 – 05/2010 Abbott Pharmaceuticals PR Ltd Barceloneta, PR

Sr. Third Party MFG (TPM) Quality Engineer

Supported the reduction of $15 millions assigned to redundant activities, identified within the Barceloneta site Quality Related Activities.

Reduced 10% of production waste, after eliminating non value added inspection activities at the packaging lines and key suppliers.

11/2005 – 05/2007 Abbott Pharmaceuticals PR Ltd Barceloneta, PR

TPM Quality Engineer

Reduced by 50% the documentation needed to initiate and support a routine change request by substituting these with a computerized system.

Performed enhancements to the key suppliers Hold system, after identification of a trend of lots released to Distribution Center with open investigations.

11/2003 - 11/2005 Abbott Pharmaceuticals PR Ltd Barceloneta, PR

TPM QA Specialist

In charge of the review/approval of Quality related investigations (plant, product complaints, trend and Laboratory) for key suppliers.

Reduced the total turnaround time for exception documents for review/approval from 2004 to 2005 by 84.3% through continuous improvement initiative.

Maintained CAPA related metrics and assembled Management Review for the Site and Division TPMs.

Active Interaction with all TMP management, directors and VPs as needed as well as MS&T and RA to assure timely support and resolution as needed.

Direct Back-up to QA/QC Site Manager

Increased and maintain a 93% of the total Batch Records release (RTFT) with No Corrections Required.

In charge of TPM Chemical Laboratory management in conjunction with TPM management to assure compliance and efficiency.

In charge of the Review/Revised and approved APR for assigned TPM, Quality/Technical Agreements, Manufacturing Instructions, Validation/Qualification Protocols and Final Reports.

08/2002 - 11/2003 Wyeth Pharmaceuticals Carolina, PR

Chemistry Laboratory Analyst

Hands on experience in a wide variety of gravimetric and volumetric analytical testing methods for Raw Materials, Formulation Blends and Finished Goods of Lyophilized Parenterals for IV administration.

Characterization and Quantification of contaminants in products using microscopes, standards and Insoluble Particle Matter detection by Light Obscuration instruments, in order to support Validations, Qualifications, Complaints and Plant Investigations.

06/2001 - 03/2002 DuPont Pharma Ltd Manati, PR

Chemistry Laboratory Analyst

Performed, reviewed and provided feedback of laboratory investigations, monthly metrics and presentations on raw materials, formulation blends and finished goods tests.

Conducted Preventive Maintenance (PM), performance qualifications and performance verifications to the instrumentation used in a daily basis in the laboratory such as HPLC, GC, and Tablet Processing Workstation II (TPW II). Tested raw materials, formulation blends and finished goods in tablet dosage forms.

10/1996 – 10/2001 US ARMY Bayamon, PR

PFC - Quarter Master Services

Performed Preventive Maintenance to heavy, medium and light weight machinery.

Provided training on SOPs and military standards.

EDUCATION

1997 - 2001 Interamerican University of PR Río Piedras, PR

B.S., Natural Sciences and Chemistry Major.

Graduated cum laude.

First place in the 1999 Biochemistry Olympics of the ACS Puerto Rico Chapter.

Third place in the 2000 Inorganic Chemistry Olympics of the ACS Puerto Rico Chapter

LISENCES & CERTIFICATIONS

Certified Lead Auditor

LEAN Mfg. Certified,

Kepner-Tregoe Project Management Certified,

Effective Communication and Conflict Mgt.

PR State Chemist Licensee.

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