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

📌 QA Specialist (Noáin)
🏢 3PBIOVIAN
📍 Noáin