Kurt Biotech - Quality Assurance Specialist

Descripción empresa:

Kura Biotech is a leading biotech firm specializing in enzymes for toxicology and multiomics applications. Committed to impactful innovation, we pioneered certified COVID-19 testing kits in 2020 and now focus on team strength and collaboration. With a foundation of scientific excellence, we extend our commitment as founders of the Liquen Foundation and certified B Corporation, working for environmental sustainability and community empowerment, striving to create a lasting positive global impact.

Misión del cargo:

The Quality Assurance Specialist ensures adherence to quality standards and regulatory requirements, maintaining the company's Quality Management System. Responsibilities include ensuring regulatory compliance, driving process improvements, maintaining quality standards, supporting cross-functional teams, and promoting a culture of excellence and communication. Knowledge of ISO certifications and regulatory compliance, coupled with essential skills like meticulous attention to detail, clear communication, and collaborative teamwork, are essential for success in this role.

Funciones del cargo:

1. Quality Standards Compliance:

• Ensure that products or services comply with the quality standards, regulations, and specifications set forth by industry guidelines and regulatory bodies.
• Research and keep updated on the national and international regulations applicable to the products marketed by the company, ensuring their compliance with the established quality requirements in production, marketing, and sales processes.
• Create, update, and maintain the necessary documentation to comply with regulatory authorities' requirements.
• Review technical documentation related to products to ensure legal and regulatory compliance in their exportation.

2. Process Improvement:

• Identify opportunities to enhance existing processes to improve product quality, increase efficiency, and reduce costs. This may involve conducting process audits, analyzing data from incidents, non-conforming products and claims, and implementing corrective actions.

3. Implementation of Quality Standards:

• Develop, implement, and maintain quality standards following ISO 13.485 regulations and supreme decrees, in conjunction with the Product Development, Operations, and Quality Control departments.

4. Support to Marketing, Sales, and Logistics Teams:

• Review technical documentation related to products to ensure legal and regulatory compliance in their exportation.

5. Maintenance of Quality System:

• Ensure the correct operation of the company's quality management system.

6. Communication and Corporate Culture:

• Communicate the company's strategic vision, as well as its production planning and corporate culture.

Condiciones y beneficios:

Your role will make a vital contribution to achieving Kura’s goals of entering the
genomics market and expanding our product portfolio. Contribute to this mission
as we expand to new markets, by doing science better and differently.

• Become a part of our unique culture here in Patagonia, where we are mission-driven and believe in open communication across all levels of the company.
• Participate in company meetings and offsite that provide insights into the business as a whole, build our team dynamics, and nurture our shared values.
• Our values are what separate us from our competition and we believe giving back to our community is just as important as driving biotech innovation.
• Participate in, or sponsor a new community project, through our Liquen Foundation.
• Experience an exceptional quality of life in one of Chile's top-ranked cities Puerto Varas, while working alongside our highly engaged team of Kurians.
• Paid English/Spanish classes to take you to the role's required level.
• Complimentary health insurance with coverage in dental, ophthalmologist, catastrophic, and life insurance, with 80% of payment from Kura.
• Daily in-office lunch with 3 menu options.
• Enjoy up to 24 days of vacation per year; 15 legal days + 1 extra day per quarter for extra rest or XL weekend + company-wide holiday between Christmas and New Year.

Requisitos:

Education:

• Biochemist, Biotechnology Engineer, or related fields.
• Proficient in English, Low Advanced level (C1). You will have to interact with international certification entities and write content in English. If you have a B2 level, we still encourage you to apply, while you are committed to improving your English with us.

Experience:

• One year or more experience in quality assurance, or regulatory affairs.
• Required experience in ISO certifications: ISO 9001, ISO 13485.
• Experience in the interpretation and implementation of regulations.

Skills & Competencies:

• Knowledge of ISO 9001, and ISO 13485.
• Knowledge of Good Laboratory Practices.
• Knowledge of internal audits.
• Responsibility, proactivity, commitment, attention to detail, organization, empathy, and teamwork.

Los/as interesados/as postular en:

If you identify with this job description, you can Apply here: https://www.kurabiotech.com/careers

Fecha de publicación de la oferta: 25/04/2024

Fecha límite de postulación: 25/05/2024