Quality Assurance Professional
2 days ago
Job Description:
We are seeking a highly skilled Quality Assurance (QA) professional to join our team at Regeneron Ireland DAC. As a QA Specialist, you will play a critical role in ensuring the quality and compliance of our biologics manufacturing operations.
Key Responsibilities:
- Review and approve batch disposition documentation to support QP release of Formulated Drug Substance
- Review QC related release data and documentation
- Complete deviation, change control & batch record reports to support disposition
- Perform status labelling of product as needed
- Represent Quality Assurance in support of deviations, CAPAs, etc
- Liaise with external partners and provide input on regulatory communications
- Train & mentor employees on processes and procedures
- Provide consultation or advice in alignment with QA policies
- Review, edit, or approve controlled documents
- Interact with various departments to ensure batch release deliverables are met
- Evaluate Regeneron processes and procedures for continuous improvement
Requirements:
- Degree or Masters in a scientific field
- 3 years experience required for Specialist level, 5+ years experience required for Sr Specialist
- Excellent organisational skills and attention to detail
- Good written, verbal and interpersonal communication skills
- Able to prioritise multiple assignments and changing priorities
- Able to learn and utilise computerised systems for daily performance of tasks
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