Gerente de Laboratorio Analítico Empleos

Descripción del trabajo

Maintain efficient operation as well as perform environmental monitoring, bacterial endotoxin testing laboratory (LAL test), Silver Content testing for medical devices and do the sterilization releases, ensuring compliance with applicable regulatory standards (FDA 21 CFR Part 820, ISO 13485, USP <85>), maintain reliability of analytical results, and proper management of human and material/component resources.

Responsabilidades

Responsible to coordinate all environmental control activities for the facility, including certifications, and the periodic review of environmental monitoring results, as well as any tasks related environmental impact, change control and biological tests
Responsible to perform and maintenance the Biocontamination assessments for the product families
Ensure compliance with Standard Operating Procedures (SOPs)
Maintain required environmental and control conditions
Manage inventory of reagents, consumables, and equipment
Schedule and coordinate test execution
Supervise, train, and evaluate laboratory technical staff
Promote continuous training and a culture of compliance
Review and approve test records and reports
Investigate deviations or out-of-specification (OOS) results
Implement corrective and preventive actions (CAPA)
Maintain technical communication with corporate and external labs
Participate in internal, corporate, and regulatory audits
Participate in method validation, improvement, and process optimization
Ensure compliance with ISO 13485, 21 CFR Part 820, and USP <85>
Prepare and review procedures and technical reports
Review and approve sterilization results prior to release

Requisitos

Bachelor’s degree in laboratory technology, Microbiology, Biotechnology, Chemistry or related field
Advanced English level
Previous experience in microbiological testing, environmental monitoring or endotoxin testing (preferably within the medical device industry)
Knowledge of regulatory standards: ISO 13485 and FDA 21 CFR Part 820
Ability to follow standard operating procedures and interpret technical documents
Advanced knowledge of MS Office tools (Excel, Word and lab software)

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Gerente de Laboratorio Analítico

Descripción del trabajo

Responsabilidades

Requisitos

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