Sr. Associate QC Systems

Amgen; Ireland; On-site; EUR 65,000 - 80,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Senior Associate, Quality Control, Investigations to own end-to-end QC investigations within the DQMS. You will author and review investigation documents, participate in triage, and drive CAPA actions to prevent recurrence, with a strong focus on root cause analysis and process improvement.

The role requires a science degree and at least four years in biotech/pharma, with solid written and verbal communication skills for technical writing, presentations, and

Qualifications

• 3rd level qualification in a science-related discipline.
• Minimum 4 years' experience in Biotechnology/Pharmaceutical setting.
• GMP investigations within a Quality System is an advantage.
• Strong knowledge of the QC function and operational savvy.
• Excellent verbal and written communication including technical writing, presentation and facilitation.

Responsibilities

• Owns and Manages Investigations for QC through the Quality Management System (DQMS).
• Author and review investigation documents.
• Participate in the investigation triage process.
• Ensure investigations are kept up to date and compliant with procedures.
• Ensure investigations result in robust CAPA to prevent recurrence.
• Seek opportunities to improve processes and management of investigations.
• Support audits and inspections regarding preparation and participation.

Skills

Technical writing

Verbal communication

Written communication

Presentation

Facilitation

Education

Science degree

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 escalation 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.