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Quality Assurance Analyst

2 weeks ago

Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

Job Summary

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This role will support the QC organization in meeting compliance targets through laboratory investigation and deviation management. The successful candidate will be responsible for reporting quality system metrics to the group and identifying improvements that can be made in all quality system inputs.

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The ideal candidate will have a strong understanding of regulatory requirements and industry standards, as well as excellent analytical and problem-solving skills. They will be able to work independently and as part of a team, with a high level of attention to detail and organizational skills.

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Key Responsibilities

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  • Authoring and peer reviewing of failure investigations/deviations relating to QC operations\
  • Reporting quality system metrics to the group and other QC functions\
  • Conducting cross-functional laboratory investigations and coordinating resources from multiple departments\
  • Representing QC on interdepartmental teams and in meetings\
  • Striving for continuous improvement in Laboratory Investigations practices to foster compliance and meet different regulatory expectations\
  • Participating in regulatory inspections as required\
  • Completing other tasks as directed by Manager\
  • Additional responsibilities may include increasing involvement in the training of employees, increasing responsibilities for authoring and reviewing documents/data, compliance representation and participation in cross-functional site meetings, and technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.\