OBJECTIVE

To provide consulting services in the area of Validation and Quality Assurance. The position may involve the development and management of validation project or Quality Assurance work that will utilize my experience as a results-oriented professional capable of producing quality work.

BACKGROUND TRAINING

Over thirty years of Pharmaceutical, Medical Device and Biotechnology experience in the areas of Laboratory Work, Quality Assurance, Regulatory Affairs, and Validation project experience with "hands on" successful accomplishments in Validation Projects. Worked and performed current Good Manufacturing Practices Audits to Pharmaceutical and Medical Device Industries in the US and internationally.

PROFESSIONAL EXPERIENCE AND MAJOR ACCOMPLISHMENTS

2003 – 2014 Quality Assurance Specialist, Amgen, Rhode Island

Responsible for managing and conducting gap assessments on all the Global Operating Standards which were applicable to the site. In this role I maintained the schedule, advice systems owners on changes and arrange for meetings to review and perform gap assessments. In addition participate in reviews of the Global Operating Standards at Corporate level and provide input to the document owners. Quality Owner for CAPA records initialized as part of the remediation effort for gaps identified.

As part of a cross training within the Site QA Department was trained in the QA Disposition Owner Role. The system is paperless and completely electronic.

Quality Systems Specialist responsible for the successful implementation of the Quality System Department. Site Member of the Corporate Team responsible for the Quality System implementation throughout the different Amgen sites. Trained site staff during the roll out of the program.

Site Complaint Owner responsible for training and mentoring the site complaint assessors and site liaison for Corporate Quality (complaint group) and the site complaint assessors. Reviewed product batch records for specific product complaint issues. Provided guidance on complaint issues for the site. Implemented strategies to minimize the response time for batch record review and visual inspection request.

NC/CAPA specialist. Currently sharing responsibilities with the NC/CAPA site system owner, which includes and is not limited to providing access to the system users, Database Training and special projects. In conjunction with the QA Training Rep from the Training Department we have support the Root Cause Analysis and Effective Nonconformance Report Writing Course provided by an external company. The course has provided information to recommend improvement to the Investigational Skills Workshop (Amgen Course). Currently, a member of the global team working with the enhancements to the Investigation Skills Workshop Course.

Manage the QA Training Program and the QA Training Manual. Organized the QA training group with the objective of harmonizing training strategies between the two site manufacturing areas. Perform the revision of the current QA Training Program Manual to improve the training offer to the QA New Hires.

Site Quality representative for a Global Learning Management System (LMS). Responsibilities included POQ Business Process Workstream Representative.

2003 - 2003 Consultant Quality Assurance-AAC, Group, Maryland (client Schering Plough, LLC-PR)

Reviewed and approved investigations written by the QC Analytical Laboratories personnel, who included raw materials, in process, bulk manufacturing, finish product, stability. The revision process includes reviewing initial request, determining the classification and level of investigation. Reviewing the corrective actions and preventive actions recommended in the investigations. Supported the personnel performing the investigations. Consulting services extended to the manufacturing operations and validation. All this effort was conducted as part of the Certification Process in relation to the commitments establish during the Consent Decree.

2000 - 2003 Senior Validation Specialist, QA Process Validation, GlaxoSmithKline, Zebulon, NC

Developed the Aerosol Technology and Validation Training for the Site. Developed Cleaning Batch Records for the Aerosol Manufacturing Lines for Comprehensive Cleaning and In-between Batch Cleaning Procedures and developed new logs for manufacturing and cleaning for the Aerosol Manufacturing Lines.

Responsible for Metered Dose Inhalers CFC and HFA Process Validations. Performed validation and process assessments in conjunction with the Product and Process Engineering Groups. Conducted internal assessments to the aerosol section validation documents against guidelines and current regulations. Assessed the Cleaning Validation Program. Responsible for the review of the new and current master batch records for the Aerosol Section (manufacturing and packaging). Coordinated the Validation Symposium held at the site for the Global Manufacturing and Supply Section.

Responsible for the development of the Validation Review for the Annual Product Reviews.

Member of the Technical Assessment Team and Expanded Investigation Team.

Member of Project Teams using Lean Sigma Approach.

In addition assisted on a vendor audit to Squibb Pharmaceutical in Humacao, PR. (Bulk Facility) and assessor of the Auditors for Validation Issues.

1998- 2000 Validation Manager, Kvaerner Process, PR

Validation Manager responsible for validation projects in PR and Latin America. Have managed projects in UK and Venezuela. Managed validation working crews in different projects in areas such as Quality Assurance, Compliance, Regulatory, process, cleaning validation, utilities and cGMP’s audits including pharmaceutical (solid-dosage, aerosols, small and large parenteral, creams, gels, medical devices, biotechnology and food industry). Project Manager responsible for the revision and approval of the Validation documents for the validation of solid dosage product (tablets). Responsible for the Validation Package review and approval for the product Celebrex at Searle Pharmaceuticals, Caguas, PR, currently, Pfizer. The validation package presented to the FDA during the PAI and was highly commended by the agency. Client satisfaction commended us with the Development of the Validation Master Plan for the new site. Project Manager for validation projects on sterile sites such as OMJ Pharmaceuticals and Wyeth.

Other responsibilities included the Technical Training Program and Business Development Program.

1993-1998 Validation Project Manager, Raytheon, San Juan, PR

Validation Project Manager responsible for validation projects in PR, Mexico, US, Venezuela, and Spain. Responsible for validation projects in PR including pharmaceutical (solid-dosage, aerosols, small and large parenteral, creams, gels, medical devices, biotechnology and food industry.

Developed SOP and Guidelines and executed the Annual Product Review Program for a Biological and Pharmaceutical Company in US. Reviewed and analyzed plant deviation reports to be included in the APR for both Pharma and Bio products at Aventis, formerly Centeon, Illinois during the Certification Process per the Consent Decree.

Performed audit to cleaning program in pharmaceutical (parenteral and solid dosage) in PR, Mexico and US. Companies included OMJ (PR), RPR (PR), Schein Labs (USA) and Promeco (Mexico).

Successfully develop the Validation Program and Department at Promeco Pharmaceuticals, Xochimilco, Mexico.

Develop a cGMP training to a pharmaceutical company in Spain focusing on both the European Community GMP’s and the CFR Title 21, Part 211 from the FDA.

Responsible for the Validation Project at Aventis, formerly Rhone Poulenc Rorer – Manati Site in PR, which included solid dosage, aerosols and creams. Validation personnel on site had a minimum of twelve-validation specialist, which included Process, Cleaning and Computer validation Specialist. In addition, manage concurrently a group of seven Computer Validation Specialist at Merck.

Project Manager responsible for the qualification of the critical utilities at Pfizer, formerly Warner Lambert during the Certification Process as part of the Consent Decree. Validation staff included 10 team members.

Compliance and Regulatory Consultant for the Puerto Rico Office, in addition to perform as Lead Auditor.

Responsible for the GMP and Technical Training Program.

1995-1996 Internal Auditor, Nycomed, PR

1989-1990 Quality Assurance Supervisor, Lifescan, PR, Inc.

1987-1989 Regulatory Specialists, Ortho Pharmaceutical, Inc. PR

1986-1987 Stability and Complaint Coordinator, Ortho Pharmaceutical, Inc. PR

1983-1985 Senior Laboratory Chemist, Baxter, PR (formerly Travenol Labs, PR)

1979-1983 Senior Chemist (Omni Research Labs, San German, PR)

1975-1979 Director Indirect Funding Program (HUD Municipal Government, San German, PR)

1971-1974 Laboratory Analyst (Omni Research Labs, San German, PR)

EDUCATION

BS in Science, Major in Chemistry, Minor in Biology - Inter American University, San German Campus. PR License Chemist # 2133 from PR.

Knowledge of Word, Power Point, Publisher and Excel. Some knowledge on Corel Drawing.

Languages: Fluent in Spanish and English, some knowledge of French.

SPECIAL TRAINING

-Project Management Course, Amgen 2010

-Advances In Process Validation, Institute for International Research, Boston, MA (2002)

-Aerosol Technology Workshop, School of Pharmacy, University of Maryland, Baltimore, Maryland (2000)

-Quality Auditor Training Program (ASQC) pending certification

-Quality Improvement Program – Ortho Pharmaceuticals, Inc. PR. (1987)

-Courses for the Renewal of the Chemist License in PR in analytical, organic, GLP’s, and GMP’s. Actively participated since 1990.

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