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 the correct execution of the activities of the Pharmaceutical Quality Management System, ensuring compliance with Good Manufacturing Practices (GMP), applicable regulatory requirements and internal procedures, through transversal participation in quality assurance processes, document management, deviations, CAPAs, change controls, validations, audits, document review and operations support.

You will also actively contribute to the maintenance of the company’s control status, support the continuous improvement of the quality system and to the culture of regulatory compliance.

1. Quality Management System (QMS)

• Manage and follow up on deviations, non-conformities, investigations and quality events.
• Manage change controls ensuring impact assessment, risks and associated documentation.
• Coordinate and follow up on corrective and preventive actions (CAPAs), verifying deadlines and effectiveness. Participate in analysis of trends and KPIs of the quality system.
• Collaborate in periodic reviews of the system.

2. GMP document management

• Draft, review, update, and archive GMP documentation:
• SOPs
• Work Instructions
• Batch records
• Specifications
• Forms
• Protocols and reports
• Ensure version control, traceability and current distribution.
• Verify compliance with Good Documentation Practices

3. Manufacturing and Operations Support

• Review manufacturing documentation and associated records.
• Perform QA support on site when required.
• Participate in line clearance, internal releases and document controls.
• Detect and escalate quality issues during operations.
• Collaborate with Production, Warehouse and QC.

4. Validations and validated status

• Participate in the execution of protocols of:
• Process Validation
• Cleanliness
• Media fill
• IQ/OQ/PQ
• CSV (when applicable)
• Write and review protocols and reports.
• Evaluate the impact of changes on validated status.
• Maintain up-to-date validation documentation.

5. Audits and inspections

• Participate in internal audits and self-inspections.
• Support in audits of customers, suppliers and authorities.
• Collaborate on CAPAs derived from audits.
• Maintain inspection readiness of the assigned area.

6. Regulatory compliance

• Provide support in regulatory activities when required:
• Documentary compilation
• Technical Answers
• Review of dossiers
• Customer Information
• Ensure that GMP documentation is consistent with approved regulatory commitments.

7. Data Integrity

• Comply with and promote ALCOA++ principles.
• Verify accuracy, completeness, contemporaneity and traceability of records.
• Detect and escalate data integrity risks.

8. Training and continuous improvement

• Maintain current training in applicable procedures.
• Participate as an internal trainer when applicable.
• Propose improvements in efficiency, compliance and robustness of the system.
• Actively participate in cross-cutting projects.

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.