Quality Control analyst

נס ציונה |
3-4 שנים |
משרה מלאה
| לפני 21 שעות
תיאור משרה

A dynamic, growing, clinical-stage, cell-therapy Biotech Company located in Ness Ziona Science Park is seeking a talented individual for the position of ’QC analyst’
Reports To: QC manager

Summary: Performs all functions relating to Drug release assays; consistent with established Current Good Manufacturing Practices (cGMP), in conjunction with all relevant Standard Operating Procedures (SOP) to ensure quality requirements are within specifications.

Responsibilities:
• Drug product release assays execution according to approved SOPs in accordance with cGMP
• Coordinate release assays sent to outsourced laboratories, record and report the results
• Validation of analytical methods
• Supports the optimization of existing methods
• Cleaning and maintenance of equipment in QC Labs
• Environmental monitoring checkup
• Write, review and approve SOPs as needed
• Report and investigate of deviations, as needed
• Support Development activities as required
• Comply with established quality, safety, and environmental procedures and policies
• Report QC Manager of unusual product observations and analytical results while analyzing or sample handling.

דרישות התפקיד

• B.Sc. in Life Sciences or Biotechnology, MSc. An advantage
• Proven academic or industrial experience with FACS analysis
• At least 3 years of experience in QC at GMP level
• Working with cells-lines, cell banking, experience in cell therapy, a major advantage
• A dynamic team worker with the ability to collaborate with other departments, capable of working in flexible hours to support production
• Well organized, reliable and task-oriented, proactive, problem-solving and troubleshooting abilities