Sr. Associate QC 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

Overview

This job specification outlines the general responsibilities associated with the role of Senior Associate, Quality Control, Investigations at Amgen Dun Laoghaire. The QC Systems team provide support to the QC function for all activities within Amgen’s Quality System associated with QC Deviation Investigations, CAPA records, Testing Results Assessments (TRA) and Change Controls.

The successful candidate will own and manage the end-to-end life cycle of Quality records on behalf of Quality Control. The role has a strong focus on technical writing and problem-solving including Root Cause Analysis and 5 Why methodologies.

Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the QC support function.

Key Responsibilities

• Owns and Manages Investigations for QC through DQMS.


• Author and review investigation documents.


• Participates routinely in the investigation triage process.


• Ensures investigations are kept up to date and compliant with procedures.


• Ensure investigations result in robust CAPA to prevent recurrence.


• Seeking out opportunity to improve the process and management of Investigations.


• Strong focus on RFT and Lean.


• Build 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 knows when to escalated or look for support

Knowledge and Experience

• Hold a third level qualification in a science related discipline


• Have a minimum of 4 years’ experience in Biotechnology/ Pharmaceutical setting.


• Proven Experience of handling GMP investigations within a Quality System an advantage.


• Detailed knowledge of the QC function and is operationally savvy.


• Excellent verbal and written communication skills including technical writing, presentation and facilitation skills.