Quality Assurance Specialist
7 days ago
The Regeneron Quality Assurance Specialist will be responsible for ensuring compliance with quality assurance policies and procedures, GMPs, SOPs, and Regeneron Standard Requirement Documents.
Key Responsibilities:
- Preparing and reviewing batch disposition documentation to support QP release of Formulated Drug Substance
- Reviewing QC related release data, documenting review
- Completing deviation, change control & batch record reports to support disposition
- Performing status labelling of product as needed
- Representing Quality Assurance in support of deviations, CAPAs, etc.
- Representing the IOPS organisation on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications
- Training & mentoring employees, including providing insights and education on processes and procedures, and conveying expectations of QA organisation
- Providing consultation or advice in alignment with QA policies
- Review, edit, or approve controlled documents
- Interacting with various departments to ensure batch release deliverables are met
- Evaluating Regeneron processes and procedures with an eye toward continuous improvement
Requirements:
- Understanding of biologics manufacturing operations
- Excellent organisational skills and attention to detail
- Good written, verbal and interpersonal communication skills and ability to optimally interact cross functionally
- Ability to prioritise multiple assignments and changing priorities
- Ability to learn and utilise computerised systems for daily performance of tasks
- Prioritise, manage multiple tasks, and meet deadlines
This role might be suitable for those who have a degree or master's in a scientific field. For Specialist level, 3 years of experience is required, and Sr Specialist requires 5+ years of directly related experience.
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