Humacao, P.R 00791

TEL. 850-8608 (Home), 852-3080, ext. 2138 (Work)

E-mail Noyolad@coqui.net

OBJECTIVE

Obtain a challenging and progressively responsible position in the manufacturing industry in the areas of Quality Control/Assurance and Materials Management.

SUMMARY OF QUALIFICATIONS

Over 15 years of experience in the Pharmaceutical industry in areas which include Warehouse and Quality Assurance. My strengths include: Effective handling of priorities, Team work oriented, Work well under pressure, Problem Solving techniques, Good interpersonal skills, Knowledge of CGMP’s, OSHA, DOT, DEA, Computer literate: Excel, Word, PowerPoint, QIS system, ISO 9000 Internal Auditor and knowledge in FDA regulations. Bilingual (Spanish/English)

ACCOMPLISMENTS/RESULTS

· Implemented Wood pallets recycling program with annual savings of $40K for last two (2) years, being recognized with a “Productivity Improvement Program” suggestion award.

· Selected in 1993 to be part of the ISO 9000 internal Auditors team.

· Negotiated Bar Code Labels prices resulting in a total cost saving of $4K for 1999.

· Implemented a reduction in Viscoelastics QA retention samples in 1997 that resulted in yearly cost saving of $16K.

· Suggested, evaluated and implemented in 1996 the application of Switching Rules from ANZI-ASQC Z.1.4-1993 used by QA inspectors that improved the statistical sampling performed by them.

PROFESSIONAL EXPERIENCE

ALCON (Puerto Rico), Inc. - Humacao, Puerto Rico

Manufacturing Pharmaceutical Plant (Ophthalmic Suspensions and Solutions, Ointments, Enzymatic Tablets, Small Volume Parenterals).

Warehouse Supervisor: Materials Department 1998 - Present

Supervise warehouse activities of 11 employees that include; Receiving, Dispatching, Reject Cage, Cycle Counts Program and Finished Goods shipping activities. Responsible for managing and controlling a capital budget of $300K. Support and implement profit improvements and special projects assigned by the WHSE manager.

David Noyola Osorio

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Plant QA Supervisor: Quality Assurance Plant QA 1990 - 1998

Direct supervision of 5 QA finished product inspectors, provide technical support in all manufacturing processes and evaluate process controls. Assure that the pharmaceutical products are manufactured in accordance to established Quality, FDA and Regulatory standards. Support the Manufacturing and Quality Assurance areas related to In-process and finished product stages. Evaluate document complaint and failure investigations. Perform statistical evaluations to the finished product when requested.

Environmental Inspector: Quality Assurance Plant QA 1989 - 1990

Perform environmental sampling in the controlled and un-controlled areas following approved schedule. Evaluate, document and perform investigations of all failures related to out of specification results. Knowledge of Clean Steam sampling, Operation of the particles count machine, operation of the Air velocity meter, STA microbiological air sampler, surface sampling by Rodac and Swabs method, operation of the RCS air sampler.

Other Alcon (P.R), Inc. Related Jobs:

QA Line Inspector: Quality Assurance Plant QA

Responsible for the monitoring, auditing and line inspection of statistically representative sample according to approved SOP’s to assure that drug product meet internal and regulatory standards of Alcon and FDA. Reconcile QA MBR accurate and on time.

Laboratory Assistance: Quality Assurance Chemistry lab

RESPONSIBILITIES -

Maintain an appropriate inventory of laboratory chemical reagents. Keep in order all controlled substances and destruction documents following adequate inventory records.

Warehouse and Receiving clerk: Materials Department

Dispatch to manufacturing areas the components following the FIFO system as per PPIC schedule. Report to the warehouse supervisor any request of finished product that may affect the FIFO system. File inventory cards following locations and FIFO system. Receive materials according to approved SOP’s and prepare the receiving report accordingly.

EDUCATION

· Turabo University, Caguas P.R

Master Degree in Material Management (Completed requisites, thesis in process)

· Interamerican University of Puerto Rico, Fajardo, Puerto Rico

BBA IN MANAGEMENT

TRAINING/SEMINARS

· How Improve Productivity in the WHSE (Training Resources Associates & Productivity Systems).

· IATA Dangerous Goods Regulations Training (DGI Training Center)

· Export Documentation and Procedures (Global Training Center, Inc. Dayton Ohio)

· Inventory Control Techniques and Management (American Management Association)

· New Federal Custom Regulations (Emery Worldwide)

· CPR Training (Alcon (P.R), Inc.)