Senior QC Analyst — GMP Analytics & Validation

Amgen; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

Amgen in Ireland seeks a QC CAS - Sr Associate to perform analytical testing of Commercial, Stability, Utilities, raw materials, and validation under minimal supervision. You will plan and execute diverse assays, report data, and support regulatory filings.

You will contribute to audits, method transfers, and continuous improvement while ensuring GMP-compliant lab practices. The role requires 4+ years in biopharmaceutical QC or related GMP lab work, strong writing and communication skills, and

Qualifications

• Bachelor's degree in a Science related field is required.
• 4+ years of biopharmaceutical QC or related GMP laboratory experience.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Responsibilities

• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple complex routine/non-routine methods and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives and projects of departmental/organizational scope.
• Review protocols and perform assay validation and equipment qualification/verifications.
• Introduce new techniques including method transfers, reports, validations and protocols.
• May contribute to regulatory filings and lab investigations as needed.
• Evaluate lab practices for regulatory compliance.
• Approve lab results.
• LIMS data coordination of commercial and import testing on site where applicable.

Skills

Communication skills

Technical writing

Presentation skills

Decision making

Teamwork

Negotiation

Investigation skills

Problem solving

Data trending

Project management

Organizational skills

Education

Bachelor's degree in a Science related field

Tools

LIMS

Job description

Amgen in Ireland seeks a QC CAS - Sr Associate to perform analytical testing of Commercial, Stability, Utilities, raw materials, and validation under minimal supervision. You will plan and execute diverse assays, report data, and support regulatory filings.

You will contribute to audits, method transfers, and continuous improvement while ensuring GMP-compliant lab practices. The role requires 4+ years in biopharmaceutical QC or related GMP lab work, strong writing and communication skills, and