Quality Assurance Specialist
About Us
At Rubió we continue to bet on new talent that will help us continue to grow as professionals within the medical-pharmaceutical sector.
Our diagnostics business unit continues to grow and as a leading biotechnology company in the development of products for the early diagnosis of diseases and metabolomics services for the scientific community and industry in the sectors of human and animal health, food, nutrition and cosmetics among others, we need to hire a new talented quality specialist.
Job Purpose/Summary
We are looking for a Quality Assurance Specialist to join our team and play a key role in maintaining and improving our quality management system.
This position ensures compliance with ISO 9001, ISO 13485, GCP, and GCLP standards, supporting our commitment to excellence in metabolomics and diagnostic innovation.
Your contributions will be essential in driving continuous improvement, maintaining high-quality standards, and supporting our research and diagnostic services.
What You’ll Do
- Author, review, and maintain Standard Operating Procedures (SOPs).
- Conduct protocol reviews and contribute to reports, as needed.
- Provide training and guidance on quality compliance for laboratory staff.
- Participate in external qualification audits and evaluations of vendors, subcontractors, and contract laboratories; address and follow up on quality issues.
- Support quality certifications and client audits.
- Identify, report, and address quality issues in a timely and effective manner.
- Contribute to process investigations, nonconforming quality events, client concerns, and CAPA plans.
- Manage change control processes.
- Maintain well-organized quality assurance records, ensuring accuracy and proper archiving.
- Participate in quality projects and change management initiatives.
- Collaborate with cross-functional teams, providing quality support across departments.
What You Bring
- Bachelor’s degree or equivalent in a scientific field (e.g., Chemistry, Biology, Biochemistry).
- Relevant experience in a laboratory operating under a certified/accredited quality management system (e.g., ISO 9001, ISO 13485, ISO 17025).
- Strong communication skills (oral and written) in both Spanish and English.
- Ability to work independently and as part of a team.
- A risk-based approach to quality management.
It Would Be Fantastic If You Have Experience In
- Quality assurance best practices under GLP/GCLP.
- Clinical regulations and standards (e.g., IVDR/MDR, ISO 14971).
- Instrument/equipment qualification, calibration, and software validation.
- Electronic data collection systems, including audit trails, Part 11 compliance, data correction, and QC.
- International clinical regulations (National and European, FDA, MHRA).
- Accredited experience in conducting audits.
What We Offer
- Stable employment with long-term career prospects.
- Flexible work options, including the possibility of remote work.
- Opportunities for professional growth and career development.
- Enjoy a range of perks, including flexible compensation, participation in group events, and exclusive discount programs.
If you are interested in this offer, please send your CV to afelis@owlmetabolomics.com before 25/04/2025.
