ELAINE DIAZ-CAVALLIERY

www.linkedin.com/in/elaine-diaz-cavalliery-b04b1942

ac3fly@r.postjobfree.com; ac3fly@r.postjobfree.com

787-***-****, 787-***-****, 787-***-****

EXPERTISE SUMMARY

Around 7 years of SAP implementation experience for different platforms (ePES and BtB) using both the Waterfall and the Agile methodology and for both Pharma and Medical Devices sectors. About 15 years of experience in the Quality & Compliance field, and 22 years in the pharmaceutical industry, with extensive knowledge of cGMP and FDA regulations in different positions. Approximately 11 years in the Environment, Health & Safety (EHS) field with technical and management knowledge of government programs and regulations such as: EPA, NPDES, RCRA, and DOT; among others.

Wide experience in different chemical and biochemistry analysis, with comprehensive analytical instrumentation knowledge, in both the academics and the industry environment. Analysis of raw materials, in-process, finished goods, and stability samples for pharmaceuticals and combination products (device/drug) following the current USP and EP compendia. Experience in: affinity chromatography, ultra filtration, lyophilization, and gel electrophoresis for proteins purification. Handling of radioactive materials, including the use of Gamma and Geiger counters for radioactive-labeled enzyme bioassays.

Computer literate in: Microsoft Office (Word, Excel, PowerPoint, Project, Visio), Statistical (Minitab), ERP (SAP), HP-ALM, Cransoft (cAPPS), TrackWise (ETS), DocSpace (Documentum), ERIS, One Source, e-LIMS, JIRA, and Confluence. Able to speak, read and write in Spanish (mother tongue), English (bilingual), Italian (conversational), and Portuguese (conversational). Certified Quality Auditor (ASQ – CQA), Process Excellence (Six Sigma) Certified Green Belt, Process Excellence – Design Excellence, FPX methodology trainee, Project Management Professional (PMP) trainee, Train-the-Trainer, and Certified ISO 14001 Lead Auditor.

PROFESSIONAL EXPERIENCE

Apr 2016 - Present

Johnson & Johnson

Janssen, Medical (Ethicon, CSS, and Synthes) – NR / SR Latam Region

Quality Management (QM) Product Owner

Agile BtB NR/SR Project

Successfully led the implementation of the QM Global Template for the NR/SR Latam countries for all sectors. Activities included onboarding and training of the assigned SMEs and consultants on the J&J BtB QM design. Approval of the QM functionalities (User Stories) for Sprint Planning based on the QM Global Template and the business user requirements. Review and approval of the related testing scripts and definition of the acceptance criteria, and data load cycles for the different stages: TAT for each Sprint, Business Simulation (BusSim) and UAT; managing of Business Readiness activities related to: impacted documentation identification (SOP), Security mapping and role assignment for End Users, and training plan for all QM End Users. Management of the assigned resources (internal and external) travel plans, vacations, work priorities, and of the QM budget within the limits of the approved CAR for the project. Maintained constant communication with key stakeholders for all countries and with the assigned site leads.

Aug 2015 – Apr 2016

Johnson & Johnson

Janssen, Medical (Ethicon, CSS, and Synthes) – NR / SR Latam Region

Data Lead (Integration) / Quality Management (QM) Product Owner

Agile BtB NR/SR Project

Managed the double role of being the Product Owner for MasterData and Quality Management, by representing the Business in the definition of the requirements to be met in the implementation of SAP BtB for the commercial and distribution centers across the Northern and Southern Region in Latin-American. As Data Lead, focus was integrating all Scrum Teams requirements to ensure adequate Master Data to support their functionalities and ensuring the right level of data quality in the conversion process for each cycle (Dev, BusSim, UAT, Production) by defining the right mapping and Business rules. Completed the implementation of the Quality Management (QM) module for Janssen Panama warehouse operations as per the Global Template and at the same time satisfied the existing J&J ERC CAPA commitment for the site. Defined and approved the QM Product Backlog for the Medical sites included in Release 2: Dominican Republic, Ecuador, Panama, and Puerto Rico.

Dec 2012 – July 2015

Johnson & Johnson

Janssen, Medical (Ethicon, CSS, and Synthes) – Latam Region

QM Master Data Coordinator / Mexico Data Lead / Janssen BR Data Readiness

Canvas Project – Back to Basics (BtB)

Responsible for planning and coordinating the data migration / conversion activities for the Quality Management (QM) Process Team for the Pharma, MDD, and Synthes sites located in Brasil and Mexico. Acted as liaison between the Local and the Global QM team and the Global Master Data team. Created the Local Functional Design Specifications (LFDS) for the QM functional objects within scope for this deployment. Provided technical support during the testing phases (Integration, BusSim, UAT) and managed the defects (identification, triage, resolution) and the corresponding documentation in HPQC. Member of the Mexico Leadership team as Data lead for the implementation of the 3 sectors: Pharma, MDD, and Synthes.

Sep 2007 - Nov 2012

Johnson & Johnson

Pharma Supply Chain - Janssen Ortho LLC – Gurabo PR

QA Quality Systems Specialist 3

Quality & Compliance Department

Review and approval of electronic Bill of Materials (BOMs) and Master Batch Records (MBRs) for the Manufacturing area within SAP (ePES) for the introduction of New Products (development, clinical, and validation) to the site and changes to existing commercial products. As APR Coordinator for the site, responsible for the oversight of the preparation of the APR / PQR reports, tracking/reporting of the metrics, and conducting the site management products review meetings. Participated as Subject Matter Expert (SME) for the development of the Pharma Data Portal (PDP) tool. Review and approval of process and laboratory investigations (events/deviations). Serve as QA participant in the Operations – Production daily meetings. Work closely with Operations to ensure cGMP, and FDA Regulations are being followed, ensuring a favorable regulatory profile. Participate as a key member in both internal (Corporate) and external audits (Affiliates and Third Parties), and regulatory inspections.

Nov 2003 – Sep 2007

Johnson & Johnson

GPSG - Janssen Ortho LLC - Gurabo PR

QA Regulatory Compliance Specialist

QA/QC/RC Department

Review and approval of validation protocols and reports, BOMs and MBRs for Manufacturing and Packaging, Change Requests, and SOPs. Responsible for the statistical analysis and preparation of the site APR reports and conducting the site management products review meetings. Review and approval of laboratory investigations (QNs). Perform internal audits of the site by systems. Gurabo’s representative in the monthly APR Coordinators meeting, driving and influencing others in the harmonization / continuous improvement process in between the US and PR sites. Participated in the pilot for establishing the APR / PQR process for the Global Janssen Supply Chain and in the one for defining the Quarterly Management Review (QMR) process. Assist in FDA, ANVISA, JFDA, and other regulatory inspections, and audits from Clients (both external and internal manufacturing), and J&J Corporate audits.

Nov 2002 – Nov 2003

Johnson & Johnson

Janssen Cilag, SpA – Cordis LLC - Latina Italy

QC Analyst

Medical Devices-QA/QC Department

Testing for domestic and international approval of new and modified medical devices to support the Global launch of a combination product (Cypher stent and others). Testing for drug stability, in-process, final product of pharmaceuticals formulations in a cGMP laboratory environment (by HPLC, GC, UV-Vis, and FTIR). Perform daily calibrations and routine maintenance on laboratory equipment. Worked in a multicultural environment and assisted in the translation of chemical and microbiological SOPs and Test Methods contributing to the organization and functioning of the laboratory. Conduct investigations and troubleshoot equipment, when necessary.

Oct 1995 – Nov 2002

Johnson & Johnson

PSGA - Janssen Ortho LLC - Gurabo PR

Environmental Regulatory Compliance Officer

Site Services Department

Responsible to assure compliance with Federal and Local regulations as well as J&J Corporate requirements. Implement and monitor environmental programs and act as liaison with regulatory agencies and J&J WorldWide Environmental Affairs. Establish and maintain all procedures and documents related to environmental compliance and perform internal audits to assure compliance with applicable regulations. Assessment, evaluation, technical support, and validation of new process, products and water systems for environmental compliance. Supervise the operation and compliance of the Wastewater Treatment Plant (WWTP). Training of employees in the handling and disposition of hazardous waste and the environmental programs. Review and approval of SOPs from all operational areas. Prepare, review and control environmental budget. Evaluate, inspect and prepare final audit report of the facility operations for regulatory compliance. Audit and qualification of suppliers for contract at the campus level (PR).

Jun 1993 - Aug 1995

High Technology Laboratory, Inc. - San Juan PR

Laboratory Analyst

Organic/Gas Chromatography Division

Troubleshooting and validation of preparation methods for environmental samples analysis. Calibration and maintenance of the laboratory instruments. Preparation and revision of analytical reports and SOPs. Validation, qualification and development of environmental methods and procedures (SOPs) for the analysis of wastewater according to EPA guidelines. Analysis of effluent samples for pre-treatment permits parameters (PRASA), waste samples, oils, soils and drinking water samples. Preparation and extraction of solid waste samples for RCRA analysis (organics and metals), analysis of metals (AA / ICP), and gas chromatography. Wet chemistry for inorganic analysis as per the “Standard Methods for the Examination of Water and Wastewater”.

EDUCATION

Turabo University, Gurabo, PR

Master of Science in Environmental Management, completed courses only (Nov 2002).

University of Puerto Rico, Río Piedras, PR

Bachelor of Science in Chemistry, Dec 1993

Oct 1991 - May 1993 - Minority Access to Research Careers Honors Undergraduate

Training Program (MARC)

PRESENTATIONS

“Effects of [Ca2+] on the Interactions of Phospholipases A2 with the Surface Membrane of Erythrocytes”. Elaine Díaz, Dr. Orestes Quesada and Dr. Reginald Morales, 26th ACS Junior Technical Meeting, University of Puerto Rico, Cayey, PR, March 16, 1991.

PROFESSIONAL AFILIATIONS

Colegio de Químicos de Puerto Rico, Q3860

National Registry of Environmental Professionals - Registered Environmental Manager, REM 9519; and Registered Environmental Property Assessor, REPA 9567

Environmental Assessment Association #14501 - Certified Testing Specialist (CTS) and Certified Environmental Specialist (CES)

American Society of Quality member (#63395671) – Certified Quality Auditor (CQA) #33238

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