About the Role
This position supports product disposition while ensuring compliance with Quality Assurance policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.
Key Responsibilities
* Preparing and reviewing batch disposition documentation for QP release of Formulated Drug Substance.
* Reviewing QC related release data and completing deviation reports to support disposition.
* Representing Quality Assurance in support of deviations, CAPAs, and external partner communications.
* Providing consultation or advice in alignment with QA policies.
* Reviewing, editing, or approving controlled documents.
Requirements
* Understanding of biologics manufacturing operations.
* Excellent organisational skills and attention to detail.
* Good written, verbal and interpersonal communication skills.
* Ability to learn and utilise computerised systems for daily performance of tasks.
* Minimum education level: Degree or Masters in a scientific field.
* Experience: Associate Level (0-2 years), Specialist Level (3 years), Sr Specialist (5+ years).