Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
Duties:
- Provide quality oversight of one or more portions of operations including, but not limited to:
- Review of GMP documentation from manufacturing, which can include but is not limited to logbooks, production batch records and electronic buffer & media batch records.
- Scanning and archiving executed production batch records.
- Ensure manufacturing adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations a plus (additional jurisdictions a plus).
- Perform other duties and projects as assigned by management.
Skills:
- Attention to detail.
- GDP understanding required.
- Microsoft Office.
- Oracle EBS.
- Ability to operate basic office equipment (e.g., scanners, printers).
- SQL, as a plus.
Education:
- Associate degree or higher
