Work mode: Hybrid

Onsite Location(s):Heredia, H, CR

About the role
Manage microbiology laboratory tasks. Supervise and coordinate microbiology testing, as per approved procedures and protocols. Validate new or existing equipment in order to assure compliance with regulatory biocompatibility and microbiology standards.
Your responsibilities include:

• Serve senior matter expert on microbiology and work environments, assuring the product meets documented requirements and that processes are controlled.
• Maintain the monitoring program of controlled environments in the Costa Rica site.
• Maintain the finished goods microbiological testing program.
• Maintain the site´s water systems monitoring.
• Make sure all Microbiology Lab procedures meet corporate requirements, as well as international regulations such as QSR/GMPs and ISO 13485.
• Lead tasks related to Microbiology Investigation Systems, such as generation of metrics and monitoring the corrective and preventive actions feeder system.
• Oversee the validation of the Microbiology Lab´s new equipment.
• Review test results and reports.
• Supervise the Microbiology Lab´s technical and professional personnel.
• Create budgets for the Microbiology Lab.
• Coordinate the purchase of the equipment needed for the laboratory´s operation.
• Participate as internal auditor in ISO 13485 and GRS/GMPS.
• Act as Quality Engineer for Facilities/ and any work environment related matters, including product transfers.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
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 degree in Degree in Microbiology, Biotecnology or related field.
• English Level required: B2:(80-89%).
• Desired knowledge: Desirable experience in ISO 13485, QSR/GMPs, Internal auditor experience is a plus. Sterilization of medical devices, Microbiology Control for Cleanrooms, Microbiology testing validation and Controlled Environment Qualification.
• At least 5 years of experience in similar position.
• Part of the Corresponding Professional Board (Incorporado a Colegio de Microbiologos) Preferred
• Please submit resume in English