Senior QA Associate, IQA - Primary Packaging

Amgen Inc. (IR); Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

Amgen Inc. (IR) in Ireland seeks a Senior Associate in Quality Assurance to support IQA activities, inspect and release primary packaging components, and serve as QA contact for incoming inspection. The role emphasizes continuous improvement and adherence to Amgen policies.

The position reports to a QA Manager and requires hands-on testing, documentation review, and cross-functional collaboration with suppliers and internal teams.

Qualifications

• Must pass eye-tests for visual inspection.
• University degree required; engineering or science preferred.
• 4+ years of relevant pharma/biotech experience.

Responsibilities

• Test primary and secondary components for use in aseptic manufacturing.
• Sample excipients and drug substance under Grade C conditions.
• Review/approve documentation for component testing for QA/QP disposition.
• Prepare and close minor NCs and CAPAs with root-cause analysis.
• Participate in supplier component customer complaint investigations.
• Provide training on testing of components and packaging.
• Assist in audits and audit preparation.
• Review and approve cGMP records and SOPs.
• Write/review/approve SOPs per Amgen policies.
• Ensure compliance with safety standards and SOPs.
• Contribute to continuous improvement and operational excellence initiatives.

Skills

Excellent communication

Cross-functional teamwork

Strong organizational skills

Problem solving

Quality mindset

Education

University degree

Engineering or Science discipline preferred

Job description

Amgen Inc. (IR) in Ireland seeks a Senior Associate in Quality Assurance to support IQA activities, inspect and release primary packaging components, and serve as QA contact for incoming inspection. The role emphasizes continuous improvement and adherence to Amgen policies.

The position reports to a QA Manager and requires hands-on testing, documentation review, and cross-functional collaboration with suppliers and internal teams.