Costa Rica-Heredia
Hybrid Roles:
About the role
Perform microbiological testing, as per approved procedures and protocols; summarize results on reports or validations. Validate new or existing equipment to assure compliance with regulatory biocompatibility and microbiology standards.
Your responsibilities include:
- Support testing related to the monitoring program of controlled environments and water system of the Costa Rica site.
- Contribute as matter expert on biocompatibility, sterilization and microbiology, assuring the product meets documented requirements and that processes are controlled.
- Perform or participate in the validation of the Microbiology Lab´s equipment.
- Contribute to maintenance of the Sterilization Dosage audit program.
- Support the Bioburden and Endotoxin (LAL) program tests of finished goods.
- Assure proper supply of reagents and materials required for lab operation.
- Support tasks related to microbiology investigation systems, such as generation of metrics and monitoring the corrective and preventive actions feeder system (OOS, CAPA).
- Act as Microbiology expert and or Quality Engineer for Facilities related matters.
- Act as Microbiology Laboratory Regent.
- Support Microbiology laboratory daily operations (reports review, test coordination, inventory management, metrics performance, etc.)
- Support as microbiology expert the transfer, modification, improvement and validation of product devices.
- Contribute to ensure microbiology lab procedures are updated.
- Support calibration and maintenance program of microbiology equipment
- Support internal and external audits.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Required Qualifications:
- Bachelor's degree or above in Microbiology.
- 2 years of related work experience
- English Level desire B2+ 80-90%
- Technical Skill in ISO 13485
- Experience in the Medical Device Industry
- Please Submit resume in English
- Affiliated to the Colegio de Microbiólogos y Químicos Clínicos de Costa Rica