Plant Quality Assurance Lead

6 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €60,000

Job Title: Quality Assurance Senior Associate

About the Role

The Plant Quality Assurance (QA) Senior Associate will report to a Senior QA Manager and be a core member of the site QA team. As Quality point of contact for manufacturing operations, this role will involve acting as a liaison between teams and ensuring compliance with Amgen safety standards and standard operating procedures.

Responsibilities
  • Perform all activities in compliance with Amgen safety standards and standard operating procedures.
  • Observe and provide real-time quality oversight and support for manufacturing on the floor.
  • Perform purposeful presence on the floor audits.
  • Perform manual pack check and deft assessment.
  • Perform Batch Review to support customer complaint investigations.
  • Provide quality support for triage and investigation of all classes of deviation events.
  • Review/approve deviations for closure ensuring compliance with appropriate standards.
  • Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Write, review and approve standard operating procedures in accordance with Amgen policies.
  • Support continuous improvement and operational excellence initiatives.
Qualifications
  • Strong attention to detail in terms of task execution and QA review.
  • Proven ability to assess both the impact of an event that occurs and the suggested path-forward.
  • Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels with the organisation.
  • Strong organizational skills, including ability to follow assignments through to completion – ability to work well on own and as part of a dynamic team.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.
  • Operational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements.
  • Problem solver.
  • Ability to do shift role 24/5.

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