About the role
We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our growing team. This role is critical to ensuring the integrity, compliance, and excellence of our cell therapy products through all stages of development and manufacturing. The Quality Assurance (QA) Specialist will play a key role in maintaining our Quality Management System (QMS), supporting GMP activities, and contributing to the advancement of our regenerative medicine pipeline.
Specific responsibilities include, but are not limited to :
* Perform review and approval of GMP documentation including batch records, quality control test data, technical reports to ensure compliance with GMP and regulatory standards
* Manage the issuance and/or revision of controlled GMP documentation including production batch records, logbooks, labels and forms ensuring compliance with document control procedures
* Maintain a document control system, ensuring that all documents are properly tracked, version-controlled, and readily available to authorized personnel
* Conduct quality investigations of non-conformances, deviations, and CAPAs, support root cause analysis and follow-up
* Collaborate with Manufacturing, Quality Control, and Process Development teams to ensure that quality is built into all processes
* Review and approve SOPs, protocols, validation documents, and change controls
* Conduct internal audits and routine QA walkthroughs in GMP manufacturing areas
* Support supplier qualification program including material release
* Support training and onboarding of personnel on QA and GMP topics
* Ensure documentation is maintained accurately and timely in compliance with GDP (Good Documentation Practices) and support the document archival process
* Maintain an understanding of regulatory trends and guidelines relevant to advanced therapy medicinal products (ATMPs)
* Support audits and inspections by regulatory agencies, clients, and internal stakeholders
Qualifications include :
* Bachelor’s degree in scientific discipline (e.g., Biology, Biochemistry, Biotechnology, Engineering or related field) is required
* 3+ years of experience in Quality Assurance within a GMP-regulated environment, preferably in cell/gene therapy or biologics industry is required
* Strong knowledge of FDA, EMA, and ICH regulations
* Excellent attention to detail and organizational skills
* Strong verbal and written communication skills
* Ability to work in a fast-paced, dynamic environment and collaborate effectively across teams
* Must be able to laugh and contribute to a positive work culture