QA Specialist (w/m/d) 100%
Infos sur l'emploi
- Date de publication :20 mars 2025
- Taux d'activité :100%
- Type de contrat :Durée indéterminée
- Langue :anglais (Courant)
- Lieu de travail :Wagistrasse 27A, 8952 Schlieren
Swissbioscience is seeking a Quality Assurance (QA) Specialist to ensure compliance with regulatory requirements and quality management systems in the processing, expansion, and cryopreservation of stem cells.
About Swissbioscience
Swissbioscience is a pioneering stem cell banking company specializing in the isolation, expansion, and cryopreservation of adipose-derived stem cells. Our mission is to provide high-quality stem cell storage solutions for potential future regenerative therapies, ensuring compliance with the highest scientific and regulatory standards.
We are seeking a highly motivated Quality Assurance (QA) Specialist 100% to join our team.
Key Responsibilities
- Develop, review, and update Standard Operating Procedures (SOPs), work instructions, and quality-related documentation.
- Conduct internal and external audits,
- Manage deviations, non-conformities, and complaints, ensuring appropriate investigation and resolution.
- Manage change controls and perform the investigations for qualification processes to ensure regulatory compliance and continuous improvement.
- Manage supplier qualification and ensure that all materials and reagents meet quality standards.
- Collaborate with QC and production teams to ensure quality control measures are implemented at every stage.
- Participate in regulatory inspections and audits by health authorities and certification bodies.
- Train staff on quality assurance protocols, regulatory compliance, and best practices.
Requirements
The Ideal candidate will require the following:
- Bachelor’s or Master’s degree in Biotechnology, Biology, Biochemistry, Pharmacy, or a related field.
- 2+ years of experience in Quality Assurance within the biotechnology, pharmaceutical, or cell therapy industry.
- Strong knowledge of GMP and regulatory requirements.
- Experience with quality audits, CAPA management, and documentation systems.
- Familiarity with stem cell processing, tissue banking, and cryopreservation is a plus.
- Excellent organizational, analytical, and problem-solving skills.
- Excellent communication in English, German is not required but will be a plus.
What We Offer
- Career growth opportunities with continuous learning and development.
- A collaborative and supportive team committed to scientific excellence.
- The opportunity to work with cutting-edge stem cell technologies.
- The chance to contribute to innovative healthcare solutions.
Join Swissbioscience and be part of a team dedicated to shaping the future of regenerative medicine through quality-driven stem cell banking solutions.
Interested candidates should submit their resume and a cover letter.
Contact
- Anas ZeinaldeenGeneral ManagerÉcrire un email