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

?Main Responsibilities:

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.

?Assessment Criteria:

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-re

📌 QA Specialist (Noáin)
🏢 3PBIOVIAN
📍 Noáin