Quality Systems QC Investigator - CAPA & Deviation

Amgen Inc. (IR); Dublin; Hybrid; EUR 53,000 - 71,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Associate, Quality Control - Investigations to own the end-to-end lifecycle of Quality records within QC. The role emphasizes strong technical writing, root cause analysis, and problem-solving while ensuring investigations lead to robust CAPA and compliant processes.

You will collaborate across the QC function, participate in audits, and support change controls as needed, with minimal supervision and broad network engagement.

Qualifications

• Hold a third level qualification in a science related discipline.
• Minimum of 4 years’ experience in Biotechnology/ Pharmaceutical setting.
• Experience handling GMP investigations within a Quality System is advantageous.
• Detailed knowledge of the QC function and operational savvy.
• Excellent verbal and written communication including technical writing.

Responsibilities

• Owns and Manages Investigations for QC through DQMS.
• Author and review investigation documents.
• Participates in the investigation triage process.
• Ensures investigations are up to date and compliant with procedures.
• Ensures investigations result in robust CAPA to prevent recurrence.
• Seek opportunities to improve process and management of Investigations.
• Support Change Controls linked to investigations and CAPAs.
• Assist audits and inspections and represent QC at site and network level.

Skills

Root Cause Analysis

5 Whys

Technical writing

Problem solving

GMP Investigations

Education

Science degree

Job description

Amgen Dun Laoghaire is seeking a Senior Associate, Quality Control - Investigations to own the end-to-end lifecycle of Quality records within QC. The role emphasizes strong technical writing, root cause analysis, and problem-solving while ensuring investigations lead to robust CAPA and compliant processes.

You will collaborate across the QC function, participate in audits, and support change controls as needed, with minimal supervision and broad network engagement.