Luis M. Rodríguez-Velázquez

*****Ballater Place

Chesterfield VA 23838

812-***-**** tqw3ll@r.postjobfree.com

804-***-****

Career Profile

Twenty two years (22) of combined experience between Pharmaceutical Industry, Medical Devices, API Manufacturing and Clinical Laboratories. Diverse background includes Medical Technologist, Microbiologist, Validation Specialist, Manufacturing Supervisor, Packaging Supervisor and Process Deviation/CAPA specialist and Compliance Analyst The manufacturing experience, quality assurance, GLP, cGMP, and scientific background encompasses a broad scope of experiences with a strong academic and solution driven methodology establishing and managing processing standards, operating procedures (SOP’s), batch records and associates training/education.

● FDA Consent Decree ● Medical devices ● API

● GMP ● Solid dosage ● Microbiology

● Bi-lingual ● Packaging ●Track Wise/CAPA

Selected Achievements

• Completed Microbiology Laboratory Start Up and 10K Class Clean Room Microbial mapping

• 500,000 plus cost reduction in Engineering and Manufacturing by empowered employees

• Participated in new products launches such as Clarinex, Celebrex, Zetia, and Exubera

• Successfully coach and motivated pharmaceutical associates toward quality improvement through FDA Consent Decree

• 50% pack-out related deviation reduction by streamlined site API Pack-out operations

Professional Experience

BOEHRINGER INGELHEIM CHEMICALS, Inc. Petersburg, VA, Unites states 2008- present

Research driven and dedicated to the discovery, development, manufacture and marketing of innovative human and animal health care products.

Complaince Analyst II

Responsible for assisting with a variety of routine activities and/or special projects in an effort to ensure compliance with US (FDA) and EU (EMEA) regulatory requirements, policies and standard operating procedures. Activities included but not limited to SOP writing, training, GMP / Housekeeping audits, equipment / tools research and purchase.

Production Supervisor

Managed, directed and coached a staff of 10 chemical technicians over 3 days on 3 day off operation. Responsible for the Active Pharmaceutical Ingredients (API) manufacturing process empathizing in safety, training, quality, housekeeping and compliance under Right the first time (RFT) culture.

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PFIZER GLOBAL MANUFACTURING Terre Haute, IN, Unites States 2007– 2008

The world's largest research-based biomedical and pharmaceutical company pioneer manufacturer of Inhaled insulin device Exubera.

Shift Team Leader (Packaging Supervisor)

Supervised and coached a staff of 30 packaging associates over 4 days on 4 days off shifts emphasizing in training, quality, safety, housekeeping and compliance. Team member of new equipment SOP development Team.

• Successful approval of new SOP for packaging equipment Bosch CUT 120 Cartoner and Domino laser encoder

• Successfully completed Thermals mapping studies to Horizontal Flow ovens using a Kaye Validator 2000 after self train

TEVA PHARMACEUTICALS, Puerto Rico 2004 – 2006

Teva pharmaceutical is the largest generic pharmaceutical in the world formerly Ivax Pharmaceutical. Manufacture of over 60 different solid dosage and capsules formulations.

Senior Production Supervisor

Managed, directed and coached a staff of 25 granulation operators in a three shift over seven days a week operation. Responsibilities comprehend safety, quality, productivity, schedule compliance, effective use of personnel, SOP revision, training, disciplinary measures, performance monitoring, promotions recommendations and absenteeism tracking. Lead the Operational Investigation Team and process improvement initiatives reporting to the Director of operations.

• Weight center usage increased up 40% due to Process improvement at Pharmacy using Lean Manufacturing initiatives

• 55% operational investigation backlog reduction within 6 month reducing over 5 millions in backorders

SCHERING-PLOUGH LAS PIEDRAS OPERATIONS, Puerto Rico 2000 – 2004

A worldwide, research-based pharmaceutical company with 55,000 global employees and 12.7 billion net revenue. Manufactures brand pharmaceutical solid dosage and capsules products.

Compression Supervisor

Supervised, leaded and mentored a staff of 20 compression / encapsulation operators in a three shift over seven days a week operation. Responsible for all operational, quality, compliance and safety parameters required to effectively run the business according to cGMP also investigate and response to customer complaints.

• Successfully coach and motivated pharmaceutical associates toward quality improvement through FDA Consent Decree

• Effectively executed FDA / Internal or Corporate Inspection Readiness Plan items & Issued Corrective Action

• Intensive interaction in multi-disciplinary teams and consultant groups such as The Quantic Group and Lachman

G.D.SEARLE & CO, Puerto Rico 1997 – 2000

G.D. Searle & Co. pharmaceutical firm owned entirely by chemical producer Monsanto Company and later acquired by Pharmacia and lasted by Pfizer. Manufacture control release products using bead coating technology.

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Process Flow Assurer (Manufacturing Supervisor)

Control Released Capsules production leader under a Self Direct Teams organizational structure. Lead and mentor a staff of 12 Bead coating and encapsulation operators in a two shift a week operation. Responsible for technical aspect of production with required dissolution data gathering, analysis, multi-departmental teamwork and process formulation calculations.

• Satisfactory start up of Bead Technology transfer to a US location

WESLEY JESSEN, INC., Puerto Rico 1990 – 1997

International manufacturer of soft contact lenses which was later acquired by Ciba vision. Manufacture comprehends polymer formulation, dry lens lathe cut, hydration, sterilization, labeling and packaging.

Production Supervisor

Supervised, leaded and mentored a staff of 30-90 associates in a three shift over seven days a week operation. Responsible for all operational, quality, compliance and safety parameters required to effectively run the business. Actively participated on development and coaching of cost savings, housekeeping and maintenance Teams.

Validation Specialist

Responsible for the IQ, OQ, PQ and thermal validation studies for Ovens, Autoclaves, Waters Baths, data analysis. Extensive experience with Kaye Digistrip 4S plus programming. Also responsible for writing validation protocols and summary reports.

Microbiologist

Responsible and leader for the Microbiology Laboratory start up project. Microbiology tests implemented water microbiology, microbiological identification, bioburden testing, sterility testing and growth promotion. Clean room class 10,000 microbial qualifications was also successfully completed

Education and Certifications

Cayey University College, University Of Puerto Rico 1981 - 1986

BS Natural Sciences.

Medical Technology School, Catholic University of Puerto Rico 1986 - 1987

Medical Technology post-graduate certification

Professional Development

Pharmaceutical Technology (Cincinnati University), Effective Presentations, Train of Trainers, Kepner Tregoe Problem Solving, Method One Pfizer (Right the First Time), Choose to Lead (Know Thy Self, Situational leadership, Inside out coaching, over the bridge),Civil Treatment for First Line Leaders

Microsoft Office, Kronos, TrackWise, ISO train, Active learner, PDOCS, PRISM, SAP, Visio

Professional License

Medical Technologist - PR License No.03418

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