QA Technician

We are a Contract Development and Manufacturing Organization (CDMO), based in Donostia-San Sebastián, currently undergoing a major growth project. We are driven by an unwavering passion for science and a strong commitment to excellence and people.

Our purpose: to improve people’s lives through groundbreaking advances in biotechnology and gene therapy that help cure rare diseases and cancer.

With a philosophy not just of working together, but growing together, our company culture is built on honesty, excellence, leadership, engagement, ethics, and rigor.

We are a CDMO (Contract Development and Manufacturing Organization), and the trust placed in us by over 50 biotech companies around the world is our greatest endorsement. We develop and manufacture viral vectors (lentiviral), and are among the European leaders operating under EMA and FDA guidelines. The lentiviral vectors produced by VIVEbiotech are used in the treatment of various diseases, including hematologic and solid cancers, as well as rare diseases.

We are looking for you to be part of our Team!

We are looking for a QA Technician to take on this key role, reporting directly to the Head of the Department.

Your mission will be to ensure that all necessary activities are carried out within the company to comply with applicable regulatory requirements and the Quality Management System in Manufacturing and Quality Control operations.

You will also play an active role in the continuous improvement of the quality system and in the implementation of new IT systems and technologies aimed at enhancing the overall performance of VIVE’s Quality department.

• Manage the execution of the Quality Management System: Change Controls, Corrective and Preventive Actions (CAPAs), risk analysis, etc.
• Manage GMP documentation: Standard Operating Procedures, Master Formulas, analytical methods, etc.
• Provide active support in the implementation of new IT systems within the Quality area (ERP, Document Management, and the management of Change Controls, Deviations, and CAPAs).
• Review and approve the execution of manufacturing instructions and analytical techniques.
• Review materials and raw materials and approve them for use in production and quality control processes.
• Take reference samples of materials and raw materials and verify QC sampling in accordance with current specifications.
• Provide support in project execution: product development, process validations, and report preparation.
• Review creation, deletion, and modification requests for materials and raw materials.
• Provide support during customer and regulatory audits.
• Provide support in project execution: product development, process validations, and report preparation.
• Provide support during audits.
• Comply with VIVE’s safety standards and contribute to their continuous improvement, reporting any incidents detected both within the area and in the rest of the company.

We are looking for someone with:

• Background in Pharmacy, Biotechnology, Biology, Biochemistry, or similar fields, complemented by knowledge of Regulatory Compliance (GMP, etc.).
• Training in Good Manufacturing Practices (GMP) as per EMA and FDA standards.
• You bring previous experience in the pharmaceutical industry in similar roles, with certification in GMP.
• Experience in risk analysis and management, as well as in the use of computerized systems applied to the pharmaceutical industry, will be highly valued.
• You are quality-oriented, with a strong sense of excellence and self-demand, and you work in an organized and methodical way.
• You proactively contribute continuous improvement ideas, offering your knowledge and experience to help achieve your department’s goals.
• You are an effective team player, proactive, and collaborative.
• You are responsible and meticulous in your work, and you’re capable of maintaining high performance when faced with demanding results and deadlines.
• You consistently demonstrate a positive attitude toward change.
• Living in Gipuzkoa, or being willing to relocate to the area, will be positively valued.

• You will have continuous career development that will help you develop your talent throughout your entire professional career.
• You will participate in innovative projects in constant technological update.
• You will have a competitive salary according to your profile for this position.
• You will have a flexible timetable, with the support you need to conciliate and balance your personal and professional life.
• You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to go ahead in the cure of diseases.
• We will support you in your personal change process, if you come from another region and wish to come to live in Donostia-San Sebastián (accommodation, support in the job placement for members of your family unit, schooling,…).
• You will enjoy a professional work environment, which is really distinguished by our humanity and closeness. And where we take care of diversity and inclusion. Diverse viewpoints, your curiosity, bring diverse capabilities that strengthen our focus and fuel our growth.
• We are proud on offering equal opportunities and a close, welcoming environment. All people receive consideration for our vacant positions, without distinction of gender, age, race, religion, identity, sexual orientation, origin, disability or any other characteristic.