Quality Assurance Medical

I am a Laboratory Technician with professional experience in the pharmaceutical industry, medical

devices and food industry. I have worked for companies such as: FoodSource LLC, ThermoFisher Scientific, DB Schenker Logistics Inc., Abbott Medical Optics, Edwards Lifesciences, Baxter, and Bristol Myers Squibb. The majority of my experience is in the Microbiology, Quality and Compliance area, sterility test, micro release, media preparation, and environmental tests. I am a team player, self-starter and organized. I have excellent interpersonal relations with co-workers and superiors. I know how to prioritize, meet deadlines and I have excellent leadership and problems solving skills. I am proficient in English and Spanish.

WORK EXPERIENCES

FoodSource LLC July 2016 -- Present

Quality Assurance and Compliance

As a quality assurance and compliance technician in FoodSource LLC, monitoring product and procedures to assure company, customer and government specification are met or surpassed a make corrective action. Monitor compliance with HACCP programs. Responsible for perform and coordinate microbiological testing of samples, prepare food samples to send to the laboratory, ATP test and water activity test for the products. Evaluate and report Microbiological data trends. Participate in the investigations of quality issues placing attention to root cause analysis and technical assessments, while ensuring accuracy of documentation contents. Attend in new projects implementation and microbiological testing transferences to/from QC Laboratory. Revise and generate documentation related to the laboratory area. Strong knowledge of relevant GMP, FDA, EU regulations.

ThermoFisher Scientific June 2016 – July 2016

Quality Inspector Middletown, VA

As a manufacturing operator in ThermoFisher Scientific I work with other technicians in the process of filling, labeling, and/or packaging of products. I ensure that we comply with GMP, ISO 13485 guidelines and the company standard operating procedures (SOPs) for the reagents and formulations line. I make sure that the materials needed to produce and pack the kits are available in the packing line. At the end of the shift I complete and reconcile work perform during the shift. I reconcile information in regards but not limited to the production, labels, labor, product fill checks, and torque checks among others.

Limary Rivera 106 Ridge Ct• Winchester, VA • 22603 Phone: 787-***-****

Email: ********@*****.***

Whenever required I clean and sanitize the work area, machines, glassware, and equipment. I operate and monitor the labeling machine and whenever required I make adjustments to it to make sure that is operating smoothly. Whenever there are temporary employees in the packing or dispensing areas I oversee and monitor their progress. On a daily basis I communicate with the assigned group to ensure the tasks and projects are completed in a timely manner. DB Schenker Logistics Inc April 2016 – June 2016

Production Coordinator Winchester, VA

. As a production coordinator I made sure that the production department meet its quality assurance and scheduling goals by planning, scheduling, executing, and directing production activities for Capri sun and Kool Aid production lines. At the end of the shift I was responsible for making sure that the goal of producing 150 pallets was achieved. On a daily basis I monitored the production and whenever the line ran out of product I coordinated with different departments to pick up and bring the product back to the line. I loaded and moved the product as needed and was in charge of reviewing, verify, and direct the movement of the shipment by location. Whenever there was a problem in the production line I was in charge of resolving it by contacting the appropriate areas within the facilities. At the end of the shift I verified and compared the product inventory reports and made adjustments. I documented the actions taken during the shift by completing forms, reports and records in the AS/400 databases. I helped the organization to accomplish their distribution and organization mission by completing related results as needed. Abbott Medical Optics 2015 – 2016

Chemical Operator Añasco, PR

As a Chemical Operator I was responsible for handling medical devices to create a variety of intraocular lenses. I performed duties related to chemical and physical testing of raw material such as EA, EMA, TFEMA, EGDMA. I was responsible for calibrating the balances to be used to measure the raw material. Utilized the column chromatography technique in the purification process. I was responsible for preparing the molds and casting using the distillation products from the raw materials. Performed visual inspections using a microscope and thickness inspections by using an Elcometer. After completing the visual and thickness inspections I was responsible for recording the data and making decision to accept or reject the product based on specifications such as color, cloudiness, cracks, bubbles, and low and high thickness. My performance was measured by the yield percentage, while in this position I maintained a monthly yield of 98 percent. Among the instruments used to to perform my duties were:

Microscopes

Calipers

Micrometers

Optical comparators

Rulers

Thermometers

Elcometer

PH meter

Edwards Lifesciences Technology Sari 2012 – 2014

QA Laboratory Technician Añasco, PR

As a Quality Assurance Laboratory Technician I was responsible for handling different samples from other pharmaceutical and medical devices companies. Among the duties assigned I identified and classified microorganisms found in specimens collected from humans, water, final products, and other sources. I isolated and maintained cultures of bacteria and other microorganisms for future study. Performed identifications of microorganisms utilizing the Microbiology Identification-Biolog System. Identified fungal cultures under a microscope by utilizing Lactophenol Cotton Blue (LPCB) stain and microscopically by utilizing a slide culture. I was responsible for maintaining and rehydrating microorganism stocks for the different companies that test were performed. I performed viability tests on microorganisms that were used in the sterilization process and in the validation process. I was responsible for the preparation and recording of medias, reagents, and buffer for the growth promotion tests of different microorganisms to validate that these medias, reagents, and buffers were prepared correctly. Whenever required, I created suspension preparation for different companies. I prepared samples and media for the dose audit test for pharmaceutical and medical devices. After dose audit test was completed I accepted or rejected the final product.

I prepared samples for the sterility process utilizing biological indicators such as Bacilus Subtilis and Atrophaeus. Whenever required I completed microbiology releases for the different companies by checking the documentation provided. Everyday I reviewed the trend charts twice a day to make sure that all the equipment being utilized in the laboratory were correct. I executed environmental tests to controlled areas to make sure that the environment where critical products where produced were free of contamination.

Baxter 2007 – 2011

Microbiologist Lab Technician Maricao, PR

As a microbiologist lab technician I performed environmental tests to make sure that the production environment for critical products was free of contamination. On a regular basis I performed bioburden testing and water sampling to determine the number of viable microorganisms on pharmaceutical products and medical devices. Whenever required I prepared the endotoxin detection testing (LAL Testing, and GEL Clot Testing) to finish goods. This test is a method used to detect bacterial toxins in the raw materials to be used in the production of medicines and final products.

On a regular basis I operated the autoclave to sterilize lab supplies, test equipment, and media. I cleaned and sanitized the environmentally controlled areas, laboratory supplies, glassware, incubators and water baths. Daily, I maintained and reviewed the logs for temperature, incubators, and other equipment used in the laboratory. I prepared samples for sterility process utilizing different biological indicators. Ensured safety standards were followed when handling biohazard waste. I was responsible for the preparation and recording of medias, reagents, and buffers for the growth promotion tests of different microorganisms. On a monthly basis I prepared reports for all customers of all the testings’ performed to the microorganisms they sent to the laboratory. Whenever a new employee and or student came to the laboratory, I was responsible for training them in all aspects such as new and existing procedures, and techniques.

Bristol Myers Squibb Caribbean, Inc 2005 – 2006

Group Leader Mayaguez, PR

As a group leader I was responsible for training new employees and certifying that the tests they conducted were done correctly to prevent customers returns and product recalls. I performed random tests of the vials created by my fellow teammates to make sure the product didn’t have any defects or abnormal patterns. I maintained an accurate inventory of the vials received, and after the testing were performed I coordinated the delivery of the vials to the respective areas. On a daily basis I prepared transactional reports depending on the operational needs. Every two weeks I was responsible for creating the schedule and certifying the timesheets of my team. EDUCATION

Interamerican University of Puerto Rico, San Germán Campus Bachelor of Science, completed: 5/2010

Minor on Microbiology

TRAINING

Good Laboratory Practices

Good Manufacturing Practices

Good Documentation Practices

Regulatory Quality Inspections

Personal Protective Equipment

Computer software knowledge in: Excel, Power Point, Word or similar. Technical reporting skil

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