Data Entry Posistion

AMGEN Manufacturing Limited */**** - Present

Juncos, Puerto Rico US

Manufacturing Associate

Manual and automated equipment cleaning, sanitization and sterilization. Solution preparation and transfer. Sample collection, processing and storage. Completion of batch records, forms, equipment/facility logs and labels. Aseptic inoculum scale-up operations. Perform routine complex and critical operation of equipment. Assist with review of documentation for assigned functions. Perform basic troubleshooting on complex operations/equipment. May provide on-the-job training and technical guidance to other team members. Recognize and accurately report problems. Able to direct others on routine tasks. Execute validation activities. Participate in the start-up, engineering runs and conformance lots of ARANESP. Also participate in the FDA approval with zero findings. Performed job with equipment such as: Allegra X-12 Centrifuge, Bioprofile Analizer 100 Plus, Innovatis CEDEX Cell Counter, Blood Gas Analyzer and Micro-Osmometer.

Lilly del Caribe 3/2004 - 3/2005

Carolina, Puerto Rico

Process Assistant

Responsible for the coordination of all manufacturing process from dispensing through printing area. Review Batch Record. Issuance of quality alerts. Ensure proper implementation of SOP’s pertaining to manufacturing, and safe working procedures. Maintain the highest quality standard in compliance with SOP’s, cGMP, and Health and Safety policies. Proven ability to work independently in a multi cultural team environment.<br/>Supervised 20 personnel in the manufacturing area. Responsible for manufacturing of lots as per master formula. Performed all duties as per the instructions of Batch Manufacturing Records, Standard Operating Procedures, Standard Cleaning Procedures and GMP. Filled batch manufacturing records of on-going products and entered data on line in the SAP. Issuance of Quality Alerts and manufacturing work orders. Sent in process samples to QA for analysis. Ensure cleaning of area and cleaning of the machines after product is over. Involved in cleaning, setting, and operating of various machines and rooms according to Standard Operating Procedures. Monitoring of Overtime, Absenteeism, and Downtime of the area.

U.S. Army 1/2001 - 8/2003

Fort Hood TX US

Chemical Specialist

Accountable for $250,000.00 in chemical protective equipment. Served as advisor and trainer on all aspect of Nuclear, Biological and Chemical operations. Provided training, advice, and supervision regarding the proper use and maintenance procedures for chemical operations in the company. Supervised and mentored 6 personnel. Conduct monthly and professional, personal and performance counseling. Performed periodic inventories to ensure accountability of all equipment. Performed minor repairs as well as lubricated and maintains equipment, using instructional books and tools. Patrolled and inspected equipment or unit to detect leaks and malfunctions. Provide hands-on training in simulated environments increasing employee confidence.

U.S. Army 8/1999 - 12/2000

South Korea

Administrative Assistant

Process personal data and maintain record and files for 170 personnel. Organize office operations to include general administrations, personnel actions, messages and form.n Prepared and evaluated reports. Enter and tracked personal data, personnel administrative actions and training/education information using an automated personnel system. Requisitioned, received, inventoried, and accounted for office equipment. Answer inquiries about personnel actions, training records, and operational records. Assist personnel in accurate and timely completion of documentation. Proficient in Microsoft Office.

EDUCATION

Universidad Metropolitana

San Juan, Puerto Rico US

Master's Degree - 12/2008

Major: Environmental Planning

Interamerican University

San Juan, Puerto Rico US

Bachelor's Degree - 5/1997

148 Semester Hours

Major: Biology

Minor: Enviromental Science JOB RELATED TRAINING Certificate,

JOB RELATED TRAINING

Environmental Management Course.

Certificate, Hazardous Material Handling Course.

Leadership Development Course.

Basic Skills for Manufacturing.

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