Sterile Release Assistant

This is a permanent-full time position to work in our Cartago site, located in Zona Franca La Lima. Medical insurance, asociation, gym, cafeteria subsidy, free transportation and other, are part of our benefits package

Job function summary

• Sterile Release Technician is responsible for conducting the release of sterile finished goods, which have been sterilized and for which the responsibility is to ensure that quality documentation are according to the requirements prior to release. 
• Major areas of accountability
• Carrying out sterile release in E1 (ERP system) after sterilization of the products and in accordance to written instructions. 
• Issuing, reviewing, updating, and implementing documents related to sterilization activities.
• Supporting Sterilization & Microbiology, Global Quality to do sterilization process validation.
• Inquiries of product status, transactions, and location in E1, due to out of the routine events.
• Ensuring necessary actions are taken in case of out-of-specification events related to the sterilization process.
• Performing physical condition check of product boxes returned from the sterilization supplier, which have been reported as damaged, and necessary actions based on damage reports.
• Monitoring the handling of products to be sterilized from a quality assurance point of view before sterilization.
• Performing post-sterilization tests on the products of the sample boxes, recording data, storing the sample boxes according to respective procedures.
• Opening and handling NCRs related to sterilization, as well as completing NCR closures on time and in accordance with local procedures.
• Timely communication out-of-specification events which require the quarantine of the products. 
• Controlling that the documentation associated to the sterilized products is revised and archived according to internal procedures. 

Responsible for 

• Performing their job in compliance with the guidelines given.
• Drawing attention to the manager to any difficulties in understanding or following the guidelines.
• Drawing attention to inefficiency of the system.
• Take responsibility for those safety aspects identified for the given position.
• Essential qualifications
• Technical Degree in Quality or Production. 
• Minimum English proficiency B1 (oral and written). 
• Minimum 1-3 years practical experience in Medical Device Manufacturing in similar positions.
• Computer knowledge and good typing skills required: MS Office (Word, Excel), Outlook and databases.

     
Preferred qualifications

• Knowledge of sterilization validation. 
• Familiar with e-beam sterilization.
• Background in sterile medical device manufacturing.

Con unos ambiciosos planes de crecimiento, Coloplast desarrolla y comercializa productos y servicios que hacen la vida más fácil a aquellas personas con necesidades de cuidados sanitarios especiales. Tenemos más de 16 000 empleados y nuestros productos están disponibles en más de 143 países. Somos una de las empresas líderes de dispositivos médicos a nivel mundial. Constantemente buscamos nuevas formas de hacer crecer el negocio : exploramos, aprendemos y buscamos nuevas formas de hacer las cosas.

Coloplast se compromete a ser una organización inclusiva, donde las diferencias son bienvenidas, las personas desarrollan su potencial y tienen un fuerte sentido de pertenencia debido a  _ no a pesar de_ sus diferencias. Por ello animamos a todos los candidatos idóneos y cualificados a presentar su candidatura independientemente de su sexo, edad, raza, nacionalidad, etnia, orientación sexual, creencia religiosa o capacidad física.

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