Overview
Plant QA Senior Associate The Plant Quality Assurance (QA) Senior Associate will report to a Senior QA Manager and is a core member of the site QA team. The QA Snr Associate will act as Quality point of contact for manufacturing operations. This is a shift role with night shifts involved.
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
* Any other tasks/projects assigned as per manager’s request.
Qualifications
* Strong attention to detail in terms of task execution and QA review.
* Proven in Risk Based Decision Making – 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
* Advising and finding a complaint path forward
* Previous Production experience
* Ability to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of ant change to cycle)
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on +353 86 126 3871 or send your CV to doconnell@berkley-group.com
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