Brainstorm is seeking an experienced Quality Assurance (QA) associate with a BSc/M.Sc. in Cell Biology/Immunology/Neurosciences willing to travel to facilities located in Jerusalem, Tel-Aviv and Petach-Tikva.
Requirements:
- BSc, preferably M.Sc. with a background in Cell Biology/Immunology/Biomedical Engineering
- A minimum of 3 years of Biotech and/or Pharma industry experience in the field of Immunology/Cell Biology/Biomedical Engineering preferably with hands-on expertise in cell-based technologies and as QA associate
- Experience and knowledge in the following areas:
- Industry experience in cGMP- compliant cell manufacturing Cleanrooms (Grade B/Grade A) production environment
- Preferably Phase III clinical trial
- CAPA management
- Change Control management
- Deviation management
- Risk Management
- Internal audits
- Vendor Qualification (Materials Controls)
- Writing, review and approving controlled documents (SOPs, batch records, test methods, forms, protocols and reports, Quality Agreements etc)
- Validation procedures
- Personnel Training
- Product Release – Review and approval of batch records
- Ability to troubleshoot problems
- Strong English language and oral communication skills
- Robust work ethic, highly committed, well organized, self-starter
- Work and coordinate with various internal departments
- Effective team player
Please send CV to hr@brainstorm-cell.com