Senior QC Analyst — GMP Analytical Leader

Amgen SA; Dún Laoghaire-Rathdown; On-site; EUR 70,000 - 90,000; Full time

Job summary

Amgen SA is seeking a Senior Associate in QC to perform analytical testing of Commercial, Stability, Utilities, raw materials and Validation under minimal supervision.

You will plan and execute analyses, validate methods, coordinate LIMS data on-site, and support regulatory filings. The role requires 4+ years in biopharmaceutical QC and strong documentation and problem-solving skills.

Qualifications

• Bachelor’s degree in Science related field is required.
• 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
• 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 procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Review protocols and perform assay validation and equipment qualification/verifications when required.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results.
• May interact with outside resources.
• LIMS data coordination of commercial and import testing on site where applicable
• May represent the department/organization on various teams.
• May train others.

Skills

Communication skills

Technical writing

Presentation skills

Escalation management

Decision making

Teamwork and coaching

Negotiation and influence

Investigation skills

Problem solving

Regulatory compliance

Technical problem solving

Data integrity

Interpreting practices

Statistical analysis

Project management

Education

Bachelor’s degree in Science

Job description

Amgen SA is seeking a Senior Associate in QC to perform analytical testing of Commercial, Stability, Utilities, raw materials and Validation under minimal supervision.

You will plan and execute analyses, validate methods, coordinate LIMS data on-site, and support regulatory filings. The role requires 4+ years in biopharmaceutical QC and strong documentation and problem-solving skills.