QC Specialist

Your mission

As QC Specialist, you will be responsible for ensuring continued Good Manufacturing Practice (GMP) – compliant activities within QC to support the manufacture and release of plasmids and gene therapy products. 
This role will be a part of aiding a GMP facility for the production of gene therapy products. As such, it will involve participating in and providing subject matter expertise in equipment qualification, method transfer and routine in-process and release testing within the QC labs, in addition to other QC-supporting activities. 

Job Description

Major Activities

• Support Technical transfer of the drug substance dilution to QC Shannon.
• Bridging study for QC dilutions to compare dilution regime in QC to previous TFF to DS dilution.
• Execution of dilution studies with including equipment installations and qualification.
• Support QC stability studies are planned, effectively tracked, monitored and achieved in accordance with agreed timelines.
• Support QC stability studies are implemented in accordance with international standards and relevant regulations.
• Support for issues, CAPAs, Change Control, Action items and risk assessment within QC.
• Ensure timely escalation and resolution of QC issues to site leadership team.
• Lead major investigations into issues impacting QC analysis.