Senior Scientist, Quality Control Specialist
4 days ago
Job Overview
The QC Raw Material team at AGC Biologics is seeking a highly skilled Senior/Principal Scientist to support the implementation of new raw materials for phase I/II projects and planning the Raw Material Qualification and Release Testing program for late-stage projects.
Main Responsibilities
- Develop and review raw material specifications based on European or US regulatory guidelines and adapt to supplier change notifications.
- Deliver scientifically sound and cGMP compliant raw material documents and analytical results.
- Promote risk assessments and create qualification protocols/reports for the raw material program.
- Oversight of sampling, both internal and outsourced testing.
Key Requirements
- MSc or PhD degree in Chemistry, Pharmaceutical Sciences, or relevant area.
- Work experience within quality control or quality assurance.
- Profound writing and reviewing skills for cGMP documents.
- In-depth understanding of US and European pharmacopoeias.
- Experience handling change controls, deviations, and CAPAs.
- Ability to work independently and as part of a high-paced team.
- Business understanding and contract manufacturing experience.
- Audit and inspection representation.
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