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

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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.

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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

📌 QA Specialist (Noáin)
🏢 3PBIOVIAN
📍 Noáin