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Suzette Arostegui

Suzette Arostegui

Senior Manager of Quality and Compliance

Sodexo on behalh of GlaxoSmithKline

Quality and Compliance Senior Manager

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Sodexo on behalh of GlaxoSmithKline

Senior Manager of Quality and Compliance

(Sodexo is a renowned world leader in delivering on-site service solutions in Corporate, Education, Health Care, and Government areas to about 10 million consumers in 6,000 global locations).

Provide Quality and Compliance support to the GSK account at the global level in the areas of Distribution & Logistics, Records Management, GMP Cleaning, Pest Control, Technical Lab Services, Lab Support, Chemical Stockrooms and Waste Management. Some aspects of this guidance include: conducting root cause analysis, deviation investigations, CAPA management, auditing and gap assessments, authoring of controlled documents, creating training materials, developing a competency program, change management, validations, utilizing lean tools for continuous improvement, etc.
Initiatives:
- Conducted a Kaizen on the US training program, which has resulted in a streamlined and more efficient program management. Duplicated efforts were eliminated and more efficient training matrices were designed.
- Proposed a monthly training program on compliance related topics for Operation Managers. This initiative was highly praised by upper management and has been rolled out as a global effort with me as lead.
I am also the Latin America lead for the global Sodexo’s Center of Excellence. In this capacity, I am leading and coordinating all activities associated with the Quality Management System implementation at 5 LATAM GSK facilities, namely Argentina, Brazil, Costa Rica, Mexico and Spain. The aim is continuous improvement and to ensure these Countries maintain their ISO 9001 certification in Quality Systems. I am responsible for ensuring that the Quality Plan and Quality Manual deliverables are met, for tracking and trending the quality metrics, providing quality and compliance support, and communicating the LATAM results to the global and regional directors, and to the European and Asia divisions during our monthly Executive meetings.

Career medium 05
Career

Sodexo

Quality and Compliance Senior Manager

Cordis

Senior Scientist / Training Consultant

Worked as an outside consultant through Precept Technology. Provided specialized training to support the analyst certification program being developed at the Quality Control analytical laboratory in the San German, PR, Cordis facility.
• Created training modules for laboratory equipment such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Headspace, and others.
• Developed and conducted “hands-on” practices where technicians applied lessons learned through the lecture sessions.

Career medium 04
Career
Career medium 01

Cordis

Failure Analysis Laboratory Analyst

(This was a temporary assignment via Kelly Scientific with the goal of facilitating the closure and completion of all patient complaints and investigations open at the time).
Investigated and executed root cause analysis on patient complaints.
• Designed a new archival system for the department's documentation. Generated a numerical system that allowed complaints to be retrieved more easily.
• Awarded by the Department’s Director for this initiative.

Career

Eli Lilly & Co.

Project Chemist

Led staff of chemists during analytical method transfers for new drug products. Improved analytical methods by proposing ideas to increase efficiency. Appointed as temporary laboratory manager when needed. Illustrated project progress to upper management by periodic oral presentations.
• Educated about 30 employees on laboratory techniques, instrumentation and methodologies as a way of improving and maintaining efficiency.
• Authored a Standard Operating Procedure (SOP) that modeled a Laboratory Deviations and Investigations program. As a result, reoccurrence of preventable deviations decreased by 99%.
• Streamlined testing cycle time by procuring the purchase of five new Hewlett Packard 1100 HPLC's. As part of this activity, had the initiative of authoring a friendly-to-use instruction manual with step-by-step instructions and pictures of how to operate the equipment. 
• Appointed by senior management to conduct internal audits and to participate in FDA inspection.

Career medium 01
Career
Career medium 06

Eli Lilly

Analytical Improver

Led a team of laboratory technicians. Coordinated analytical testing for final product release. Executed troubleshooting of laboratory equipment.
• Spearheaded initiative to develop and execute a project to eliminate non-regulatory testing from a product-testing plan. This resulted in a reduction in cycle time and operational costs of approximately $200K per year.
• Persuaded local management for adding another technician to the area, to help reduce time of analysis. Reduced time of analysis from 5 to 3 days per lot.
• Played pivotal role as liaison between Corporate Reference Standards Dept and laboratory. Maintained inventories, trained lab personnel on corresponding procedures (SOP's) and conducted internal audits.
• Ensured compliance with Corporate Policies by conducting assessments to ensure the laboratory procedures were aligned with corporate directives.

Career

McNeil Consumer Healthcare

Senior Scientist/Stability Liaison

I worked as a contractor through Innovative Pharma Solutions (IPS).

Senior Scientist/Stability Liaison, QA/R&D (04/2010-11/2011)
Worked as a contractor through Innovative Pharma Solutions (IPS). Main responsibilities included coordinating the notification, preparation, review, and completion of the stability section for the Annual Report of all products manufactured at McNeil.
• Pivotal point between R&D, QA, QC Labs, Regulatory Affairs and sub-contractors. Established good rapport and business relations to ensure completion of tasks within tight deadlines.
• Provided support on as-needed basis to the post-FDA audit remediation team (i.e., review company’s product specifications, auditing of reports, etc). Additionally, served as internal auditor of validation documents (i.e., reports, data tables, etc).
• Initiative: Conducted a gap assessment of the process of reporting the stability section of the Annual Report identifying gaps and proposing corrective measures.

Career medium 05
Career
Career medium 01

Cordis/ Johnson & Johnson

Sr. Scientist - Analytical and Materials Science

Led multimillion-dollar projects to execute changes in raw materials, formulations, suppliers, specifications and vendors. Worked extensively with outside vendors and external laboratories to speed delivery times and workflow, and to coordinate external testing. Interacted with regulatory, quality, laboratory, engineering, production and financial departments to maintain team efforts within timelines.

• Played instrumental role in the implementation of materials' changes by creating, coordinating and/or executing validation strategies, change management strategies, protocols, reports, engineering studies, investigations, and product specifications.
• Facilitated 30-day submission to FDA for a product specification change.
• Reviewed laboratory data for accuracy. Participated in the review of analytical protocols and reports.
• Aligned a raw material assay test with the United States Pharmacopoeia (USP) as part of an interdisciplinary team; consisting of regulatory, planning, strategic sourcing, analytical development, and production contacts; responsible for implementing the change. Resulted in a reduction in time of analysis by changing from a Residue on Ignition (ROI) test to a complexiometric test.
• Averted production interruption by coordinating and leading the efforts of submitting an emergency change associated to a raw material.

Career

Cordis

Cleaning Validation Scientist

Provided support and/or expertise as subject matter expert to Cordis sites in Belgium, Italy, Netherlands, Ireland, Puerto Rico, and Miami. Position included 20% traveling.
• Promoted within a year from being an Engineer II to becoming a Senior Scientist.
• Improved the state of compliance by rewriting 40 cleaning standard operation procedures (SOPs).
• Authored a global cleaning validation procedure that harmonized cleaning practices at a global level.

Career medium 06
Career

Puerto Rico Board of Chemists

Chemistry

University of Puerto Rico - Mayaguez Campus

MS, Organic Chemistry

University of Puerto Rico - Mayaguez Campus

B.S., Chemistry (minor in math)