Quality Assurance Specialist

Our Organization

FairJourney Bio is a globally recognized Contract Research Organization (CRO) specializing in antibody discovery, engineering, characterization, and production. We proudly serve leading pharmaceutical companies and top-tier biotech firms across the U.S., Europe, and Japan. Our cutting-edge facilities are based in Porto, Portugal, where innovation and scientific excellence drive every project. For more information, please visit FairJourney Bio (fjbio.com).

The Role

We are seeking a motivated and detail-oriented Quality Assurance Specialist experienced in quality assurance and quality management systems. The successful candidate will support the implementation, maintenance, and continuous improvement of our Quality Management System (QMS), with a strong focus on compliance with OECD Good Laboratory Practice (GLP) Principles.

Key Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System in accordance with OECD GLP Principles.

• Ensure compliance with internal procedures, quality standards, and applicable regulatory requirements.

• Participate in the preparation, review, control and management of quality documentation, including SOPs, WIs, policies, records, validation protocols, and reports.

• Plan, conduct and report internal audits/inspections and follow-up activities.

• Conduct and support the investigation and resolution of non-conformances, deviations, CAPA (Corrective and Preventive Actions) processes, change control, and risk assessment activities.

• Monitor quality metrics and contribute to continuous improvement initiatives.

• Coordinate with various departments to ensure timely completion of quality tasks and compliance with internal timelines.

• Provide guidance and support to investigation teams regarding quality system requirements and best practices.

• Conduct and support training activities related to quality procedures and compliance requirements.

• Support authorities’ inspections, external audits, and client quality assessments when required, including preparation of materials and participation during audits.

• Maintain accurate, organized and up to date quality records and documentation.

• Stay current on industry regulations and best practices to ensure the company’s quality assurance processes remain compliant.

Your Profile

• Bachelor or master’s degree in Life Sciences (Biotechnology, Biochemistry, Microbiology, Chemistry, or related field).

• 3+ years of experience in Quality Assurance or a related quality management role.

• Good understanding of quality assurance principles, documentation practices, and audit processes.

• Strong organizational and time management skills

• Attention to detail and ability to review and analyse data accurately.

• Excellent written and verbal communication skills in English.

• Ability to work independently and collaboratively in a multidisciplinary environment.

• Proficiency in Microsoft Office applications.

Nice to Have:

• Hands-on experience in ISO 9001 environments and knowledge of Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP) standards.

• Experience supporting audits and regulatory inspections.

• Basic knowledge of regulatory guidelines and standards in the biotech or pharmaceutical industries is desirable.

• Experience with quality management systems (QMS) is an advantage.

We Offer

• Integration in a highly motivated team

• Working in an international environment

• Employee benefits package

• Career development

If you’re ready to take the next step in your career path, we’d love to hear from you.

Deadline for applications: June 30th