- Review other documentation associated with new product, drug substance and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.)
- Provide quality oversight and direction for Material introduction process and external party management.
- Development & monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested.
- Maintain the approved supplier management list within the qualified Supplier Management system by ensuring that all suppliers and materials used at Carlow are correctly set up.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
- Bachelors Degree or higher preferred; ideally in a related Science discipline
- Lean Six Sigma Methodology experience desired.
- Knowledge of cGMP and GDP preferred
