We are looking for a QA Specialist (QC Laboratory) to join our Quality Assurance Team.

As QA Specialist (QC Laboratory) , your responsibilities will include:

- Act as the Quality Assurance representative within the Quality Control laboratory, ensuring compliance with GMP regulations and quality standards.
- Provide active QA on-the-floor support, ensuring immediate quality guidance and promoting GMP and documentation best practices across laboratory activities.
- Perform critical review of analytical documentation, laboratory records, calculations, chromatograms, integrations, analytical results and raw data.
- Ensure Data Integrity compliance following ALCOA+/ALCOA++ principles, guaranteeing traceability, reliability, availability and integrity of both electronic and paper-based records.
- Oversee GMP-compliant use of laboratory computerized systems and equipment, including LIMS, Empower 3, Gen 5 and other analytical platforms.
- Review user access management, audit trails, backups and data archival processes whenever applicable.
- Participate in deviation investigations, root cause analysis, impact assessments and CAPA definition, implementation and effectiveness verification.
- Prepare, review and improve SOPs related to Quality Control, Data Integrity, raw data management, computerized systems and audit trail reviews.
- Support the qualification and training of laboratory personnel in GMP requirements, Data Integrity principles and Good Documentation Practices.
- Support analytical method validation and transfer activities, ensuring compliance with applicable regulatory requirements.
- Collaborate closely with QC, QA, IT,



Validation and other cross‑functional departments to maintain a culture of quality and continuous improvement.
- Bachelor’s degree in Chemistry, Biotechnology, Biology, Biochemistry, Pharmacy or other related scientific discipline.
- Minimum 4 years of experience in QA, QC or equivalent roles within a GMP-regulated pharmaceutical or biotechnology environment.
- Proven experience in raw data review, analytical results verification, deviation investigations, CAPA management and GMP documentation.
- Strong knowledge of GMP requirements, Good Documentation Practices and Data Integrity principles.
- Working knowledge of EU GMP Annex 11, FDA 21 CFR Part 11 and GAMP 5 regulations.
- Experience with laboratory computerized systems such as LIMS, Empower 3 and/or Gen 5.
- Knowledge of analytical techniques including HPLC, UPLC, UV, IR, ELISA and microbiological/biological methods.
- Experience in analytical method transfer and validation activities will be highly valued.
- Master’s degree or postgraduate qualification in Quality, Pharmaceutical Industry, Computerized Systems Validation (CSV) or Data Integrity will be considered an asset.
- Spanish fluent and English B2/C1 level, with the ability to review GMP documentation in English.
- Previous experience in biotechnology/CDMO environments working with recombinant proteins, monoclonal antibodies, biosimilars,



ADCs or other biologics will be highly valued.
- You will have 26 paid days off: 23 vacation days + 2 personal days + 1 day off set by the company.
- Adaptable compensation plan, allowing all employees to allocate up to 30% of their gross annual salary to daily services exempt from income tax (childcare, health insurance, training, etc.).
- Company benefits club, which allows 3P employees to obtain exclusive prices and discounts on a multitude of products and services (Booking, Fnac, Rituals, El Corte Inéls, etc.).
- Flexible working hours during the week and a reduce work day on Friday of 7h.
- Special Summer working day of 7h during July and August.
- 3PBio is committed to the continuous, updated and personalized improvement of our personnel’s learning. To this end, we have Learning & Development department, who is in charge of creating personalized, individualized and differentiating career plans for our employees.
- The company continues to focus on internal talent and stable employment, focusing on upskilling and reskilling. We offer opportunities for professional growth and take an environment of trust.
- We encourage the participation of our employees in solidarity events such as charity races, social donations...
- We have several programs aimed at improving the physical, psychological and emotional well-being of our employees. In this context, we participate in the Corporate Challenge, promote healthy lunches and comfortable and safe work spaces.
- We have a high-impact work environment with flat hierarchies and short decision‑making processes.
- All new hires who reside ou

📌 QA Specialist (Noáin (Valle de Elorz))
🏢 3PBIOVIAN
📍 Noáin (Valle de Elorz)