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.

📌 Qa Specialist (Pamplona)
🏢 3PBIOVIAN
📍 Pamplona