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Quality Assurance Specialist - Day Shift - Orca Bio
Software Engineer
Quality Assurance Specialist responsible for ensuring cell therapy products meet regulatory standards through rigorous manual and automated testing, SOP creation, and data analysis. Focus on GxP compliance and continuous improvement in a fast‑paced biotech environment.
About the role
Key Responsibilities
- Design, execute, and document manual and automated test cases for cell therapy manufacturing processes.
- Develop and maintain SOPs, ensuring alignment with GxP and regulatory requirements.
- Analyze test data, identify trends, and recommend corrective actions to improve product quality.
- Collaborate with cross‑functional teams (R&D, Manufacturing, QA) to troubleshoot issues and implement process improvements.
- Participate in audits, inspections, and regulatory submissions, providing accurate documentation and evidence of compliance.
Requirements
- 3+ years of QA experience in a regulated biotech or pharmaceutical setting.
- Strong knowledge of GxP, SOP development, and quality systems.
- Proficiency in manual testing and experience with automation tools (e.g., Selenium, TestRail).
- Excellent analytical, problem‑solving, and communication skills.
- Ability to work independently and collaboratively in a dynamic, fast‑paced environment.
Skills
software developmentsystem designproblem solving