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Gracias por aplicar al anuncio de empleo Bq specialist, en Cardinal health
Este anuncio de empleo ya no está disponible. Conoce todos los anuncios de empleo que tenemos publicados.
Salario confidencial CRC
Costa Rica Toda Costa Rica Toda Costa Rica Toda Costa Rica
Publicado 12 Sep 2017 2017-9-12 12/10/2017
This position is responsible to work with and guide the efforts of Microbiology and Environmental Monitoring Department personnel to assure test results, procedures, and methods are written, maintained and executed in conformance with current Industry and Corporate requirements. There is also responsibility to oversee the fulfillment of biocompatibility requirements for product/component changes as well as Sterilization ownership at the site level (EO and Gamma processed devices).
Essential Functions:
1. Provide timely microbiological testing service, assisting as a working team member as necessary (requires knowledge of all microbiology jobs)
2. Interpret and trend the results of continuous monitoring activities to prevent issues and determine preventive actions to minimize impact to product and the operation
3. Implement on-going studies to document the scientific suitability of test methodologies fundamental to conformance and assessment.
4. Carry out method development/validation work with minimal assistance.
5. Perform training of microbiology personnel and other site personnel on relevant microbiology topics.
6. Ability to keep accurate records and performs monthly trend analysis for microbiology data to identify potential concerns with product quality and correct deviant situations.
7. Performs studies to support the validation of test methods and ongoing validation studies as needed.
8. Ability to write effective investigations for out of trend results, exceeded alert and/or action levels.
9. Write, review and update technical procedures
10. Knowledge of applicable regulatory standards
11. Participates in CAPA, NCR, and SCAR Programs
12. Support and implement Cost Saving projects
13. Supervisory role for technician-level personnel
Minimum Bachelor’s Degree in Microbiology, Biotechnology Engineering or related field.
o Minimum 5 years working in Microbiology.
o Medical devices industry experience is a must.
o Knowledge of sterilization (EO and GAMMA) is a must.
o FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations experience
o Strong problem solving skills
o Validation
o Microsoft Office (Word, Excel, Outlook, PowerPoint, Project)
Profesional
Licenciatura
Ingeniería Industrial
Ingenierías Otras
Microbiología
5 años de experiencia
Ingeniero
1 Vacante
Minimum Bachelor’s Degree in Microbiology, Biotechnology Engineering or related field.
o Minimum 5 years working in Microbiology.
o Medical devices industry experience is a must.
o Knowledge of sterilization (EO and GAMMA) is a must.
o FDA Regulated Industry experience as well as applicable Quality System Standards and Regulations experience
o Strong problem solving skills
o Validation
o Microsoft Office (Word, Excel, Outlook, PowerPoint, Project)
Competencias para la vacante
Profesional
Ingeniero
Licenciatura
Equipo medico
5 años de experiencia
713062
Gracias por aplicar al anuncio de empleo Bq specialist, en Cardinal health
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