QA Technician

Description

Job Summary: We are seeking a QA Technician to ensure regulatory compliance and the Quality Management System, supporting continuous improvement in biotechnology and advanced therapies. Key Highlights: 1. Join a leading international biotechnology company with global expansion. 2. Contribute to the continuous improvement of the quality management system for advanced therapies. 3. Opportunity for professional development within an innovative and dynamic team. **About Us** ------------------ We are an industrial company **internationally recognized as a leader in biotechnology and advanced therapies, headquartered in Donostia\-San Sebastián, with an ambitious expansion project, an unwavering passion for science, and a commitment to excellence and people.** Our **purpose:** to improve people’s lives through revolutionary advances in biotechnology and gene therapy that cure rare diseases and cancers. Guided by a philosophy of not only working together but also growing together, our client’s culture is built upon honesty, excellence, leadership, engagement, ethics, and rigor. We are a **CDMO** (Contract Development and Manufacturing Organization), and **the trust placed in us by over 40 biotechnology companies worldwide is our strongest endorsement.** We develop and manufacture viral vectors (lentiviral), ranking among Europe’s leaders and operating in full compliance with EMA and FDA regulations. Lentiviruses produced by VIVEbiotech are used to treat various diseases, including hematological and solid cancers, as well as rare diseases. **We’re looking for you to join our Team!** ### **Your Role** We are seeking a **QA Technician** to fill this key position 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” for Manufacturing and Quality Control activities.** Additionally, you will provide **active support for the continuous improvement of the quality system and for the implementation of new information systems and technologies aimed at enhancing VIVE’s overall Quality area.** ### **Your Responsibilities** * Manage execution of the Quality Management System: Change Controls, Corrective and Preventive Actions (CAPAs), Risk Assessments, etc. * Manage GMP documentation: Standard Operating Procedures, Master Formulas, Analytical Methods, etc. * Provide active support during implementation of new Quality-area information systems (ERP, Document Management, and Change Control, Deviation, and CAPA Management). * Review and approve execution of manufacturing and analytical technical guidelines. * Review raw materials and excipients and approve them for use in production and quality control processes. * Collect reference samples of raw materials and excipients and verify QC sampling procedures against current specifications. * Support execution of projects: product development, process validations, and report preparation. * Review additions, deletions, and modifications of raw materials and excipients. * Support execution of customer and regulatory audits. * Support execution of projects: product development, process validations, and report preparation. * Support execution of audits. * Adhere to VIVE’s safety standards and contribute to their continuous improvement by reporting incidents both within your own area and across the company when identified. ### **What We Value in You** You are who we are looking for if you have: * A degree in Pharmacy, Biotechnology, Biology, Biochemistry, etc., complemented by knowledge of Regulatory Compliance (GMP, etc.) * Training in Good Manufacturing Practices: EMA and FDA * Prior experience in the pharmaceutical industry in similar roles, with certification in Good Manufacturing Practices. * Experience in risk analysis and management, as well as in using information systems applied to the pharmaceutical industry, will be valued. * Furthermore, you are a person oriented toward high quality (excellence and self-demand), organized and methodical. * You proactively propose ideas for continuous improvement and share your knowledge and experience to help achieve your Department’s objectives. * Ability to work effectively within a team and demonstrate proactivity. * You are responsible and rigorous in your work, demonstrating strong work capacity under high performance expectations and tight deadlines. * You consistently maintain a positive attitude toward change. * Residency in Gipuzkoa (or intention to relocate to the area) will be viewed favorably. ### **What We Offer You** * Continuous career development to help you grow your talent throughout your professional journey. * Participation in innovative projects undergoing constant technological updates. * A competitive salary commensurate with your profile for this position. * Flexible working hours, supported by the resources you need to balance your personal and professional life. * Membership in an expert, young, dynamic, innovative, and enthusiastic team united by a common purpose: supporting our clients in advancing cures for diseases. * Support during your personal relocation process, if you come from another region and wish to move to Donostia\-San Sebastián (housing, employment integration for family members, school enrollment, etc.). * A professional work environment truly distinguished by our humanity and closeness, where diversity and inclusion are actively nurtured. Diverse perspectives and your curiosity bring varied capabilities that strengthen our approach and drive our growth. * We proudly offer equal opportunities. All individuals receive equal consideration for our open positions, regardless of gender, age, race, religion, identity, sexual orientation, origin, disability, or any other characteristic.