Description

You will provide quality and compliance oversight for commercial and investigational product manufacturing through direct shop floor presence in Morrisville, NC.

Responsibilities

• Inspect and disposition raw materials and components using the Slingshot ERP system to ensure compliant material release.
• Review vendor documentation, including CoA, CoC, and CoS, to verify compliance with master specifications.
• Perform QA review and approval of completed manufacturing batch records and logbooks for Manufacturing, Engineering, Quality, and Warehouse departments.
• Collaborate with stakeholders to ensure rejected or released materials are transferred to the correct locations.
• Assess and identify risks for mitigation and communicate findings to relevant stakeholders.

Required Skills

• B.S. in chemistry, biological, pharmaceutical sciences, or a related discipline.
• Minimum of 3 years of experience in the biotech or pharmaceutical industry.
• Direct experience working within a cGMP manufacturing environment.
• Strong working knowledge of FDA requirements and guidance documents.
• Experience with manufacturing batch record review or analytical analyses.
• Proficiency using Slingshot ERP.
• Ability to work on-site on a 2-2-3 shift rotation, including weekends.

Preferred Skills

• Working experience with KNEAT, Blue Mountain RAM, or VEEVA.

Key Skills

Education

Any Graduate