Quality Assurance Specialist

About the role

FairJourney Bio, a global CRO focused on antibody discovery and production, is looking for a motivated Quality Assurance Specialist to support its Quality Management System (QMS) and ensure compliance with OECD Good Laboratory Practice (GLP) principles.

Key responsibilities

• Maintain and continuously improve the QMS in line with OECD GLP principles.
• Ensure compliance with internal procedures, quality standards, and regulatory requirements.
• Prepare, review, control, and manage quality documentation such as SOPs, work instructions, policies, validation protocols, and reports.
• Plan, conduct, and report internal audits and follow‑up activities.
• Investigate non‑conformances, deviations, and manage CAPA, change control, and risk assessments.
• Monitor quality metrics and drive continuous improvement initiatives.
• Coordinate with cross‑functional teams to meet quality task deadlines.
• Provide guidance on quality system requirements and support training activities.
• Assist with external audits, client assessments, and regulatory inspections.
• Maintain accurate and up‑to‑date quality records.

Required profile

• Bachelor’s or master’s degree in Life Sciences (Biotechnology, Biochemistry, Microbiology, Chemistry, or related field).
• At least 3 years of experience in Quality Assurance or a related quality management role.
• Strong understanding of quality assurance principles, documentation practices, and audit processes.
• Excellent written and verbal communication skills in English.
• Ability to work both independently and collaboratively in a multidisciplinary environment.

Required skills

• Proficiency in Microsoft Office applications.