Lead QC Investigations & CAPA Systems

Amgen; Dublin; On-site; EUR 65,000 - 85,000; Full time

Job summary

Amgen Dun Laoghaire seeks a Senior Associate in Quality Control, Investigations, to own end-to-end QC investigations and related records within the Quality System. The role emphasizes technical writing, root cause analysis, and 5 Why methodologies to drive robust CAPAs.

You will interact with ADL networks, support change controls linked to investigations, and participate in audits and inspections, operating with minimal supervision and strong problem-solving skills.

Qualifications

• Hold a third level qualification in a science-related discipline.
• Minimum 4 years’ experience in biotechnology/pharmaceutical settings.
• Experience with GMP investigations within a Quality System.
• Detailed knowledge of QC function and operational savvy.
• Excellent verbal and written communication including technical writing, presentation and facilitation skills.

Responsibilities

• Owns and manages QC investigations through DQMS.
• Author and review investigation documents.
• Participates in the investigation triage process.
• Ensures investigations stay up to date and compliant with procedures.
• Ensures investigations result in robust CAPA to prevent recurrence.
• Seeks opportunities to improve the process and management of investigations.
• Maintains strong focus on RFT and Lean.
• Builds relationships and partners at ADL and in the network.
• May own Change Controls linked to investigations and CAPAs.
• Supports audits and inspections regarding preparation and participation.
• Represents QC at site and network level regarding investigations.
• Works with minimal supervision but escalates when needed.

Skills

Strong communication

Technical writing

Presentation skills

Facilitation skills

Education

Bachelor's degree in a science-related discipline

Job description

Amgen Dun Laoghaire seeks a Senior Associate in Quality Control, Investigations, to own end-to-end QC investigations and related records within the Quality System. The role emphasizes technical writing, root cause analysis, and 5 Why methodologies to drive robust CAPAs.

You will interact with ADL networks, support change controls linked to investigations, and participate in audits and inspections, operating with minimal supervision and strong problem-solving skills.