Quality Assurance Specialist

7 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time
Job Description:

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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