Senior IQA QA Associate - Packaging & CI

Amgen SA; Dún Laoghaire; On-site; EUR 60,000 - 90,000; Full time

Job summary

Amgen in Ireland seeks a Sr. Associate in Quality Assurance to join the IQA function, focusing on inspection and release of primary packaging components. The role reports to a QA Manager and acts as the QA contact for Incoming Inspection of primary and packaging components.

The site emphasizes continuous improvement; additional tasks may be assigned to support site CI activities while ensuring compliance with Amgen policies and safety standards.

Qualifications

• Bachelor's level degree in engineering or science required.
• Minimum 4 years in pharma/biotech, or equivalent.
• Eye-tests for visual inspection must pass.

Responsibilities

• Test primary and secondary components for aseptic products.
• Sample Excipients and Drug Substance under Grade C.
• Review and approve testing documentation for QA disposition.
• Compile and close minor NC and CAPA with root-cause focus.
• Participate in supplier/customer complaint investigations.
• Provide training on component and packaging testing.
• Participate in audits and audit preparations.
• Review and approve cGMP records (WO, JP, GDMS, NC, CAPA, SOPs).
• Write, review and approve SOPs per Amgen policies.
• Adhere to Amgen safety standards and SOPs.
• Support continuous improvement initiatives.

Skills

Eye-tests

Cross-functional teamwork

Communication skills

Problem solving

Organizational skills

Root cause analysis

Aseptic operations

Education

University degree in Engineering or Science

Job description

Amgen in Ireland seeks a Sr. Associate in Quality Assurance to join the IQA function, focusing on inspection and release of primary packaging components. The role reports to a QA Manager and acts as the QA contact for Incoming Inspection of primary and packaging components.

The site emphasizes continuous improvement; additional tasks may be assigned to support site CI activities while ensuring compliance with Amgen policies and safety standards.