QA Specialist-(Batch Release)-Multi Level

1 week ago


Dublin, Dublin City, Ireland Regeneron Full time

Performs activities in support of disposition of product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

As a typical day may include the following:

  • Preparing & reviewing of batch disposition documentation to support QP release of Formulated Drug Substance
  • Reviewing of QC related release data, Documentation review
  • Completing deviation, change control & batch record reports to support disposition
  • Performing status labelling of product as the need arises
  • 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
This role might be for you if:
  • You have an understanding of biologics manufacturing operations
  • You have excellent organisational skills and attention to detail is essential
  • You have good written, verbal and interpersonal communication skills and the ability to optimally interact cross functionally
  • You have the ability to prioritise multiple assignments and changing priorities
  • You have the ability to learn and utilise computerised systems for daily performance of tasks
  • You have the ability to prioritise, manage multiple tasks, and meet deadlines
To be considered for this opportunity you must have a Degree or Masters in a scientific field. Associate Level requires 0-2 years experience, for Specialist level 3 years experience is required and Sr Specialist you must have 5+ years experience directly related experience.#J-18808-Ljbffr
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