The Quality Assurance Specialist will support a GxP-regulated Life Sciences manufacturing environment, providing Quality Validation oversight for a new Advanced Therapy facility.
Requirements
- Strong knowledge of Equipment Lifecycle Management processes.
- Hands-on experience with validation and qualification of GxP laboratory and process equipment.
- Experience reviewing and approving Standard Operating Procedures (SOPs).
- Working knowledge of Computer System Validation (CSV) and Data Integrity principles.
- Experience with Change Management processes.
- Proficiency navigating and documenting activities within electronic quality systems in compliance with GDP.
Benefits
- Paid Time Off
- Paid Holidays
- Medical
- 401K Match