Senior QC Associate - GMP Lab & Data

Amgen; Ireland; On-site; EUR 53,000 - 71,000; Full time

Job summary

Amgen in Ireland is seeking a QC CAS - Sr Associate to support analytical testing across Commercial, Stability, Utilities, raw materials and validation. You will ensure quality of your tasks, contribute to milestones, and aim for first-time right outcomes.

Flexibility for extended hours and weekends may be required. You will plan and perform analyses, validate methods, coordinate LIMS data, and engage with stakeholders to maintain regulatory compliance and data integrity.

Qualifications

• Bachelor's degree in a Science-related field is required.
• 4+ years of biopharmaceutical QC or 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 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

Analytical testing

GMP knowledge

Data trending

Technical writing

Problem solving

Teamwork

Project management

Communication

Auditing

Education

Bachelor's degree in Science

Tools

LIMS

Job description

Amgen in Ireland is seeking a QC CAS - Sr Associate to support analytical testing across Commercial, Stability, Utilities, raw materials and validation. You will ensure quality of your tasks, contribute to milestones, and aim for first-time right outcomes.

Flexibility for extended hours and weekends may be required. You will plan and perform analyses, validate methods, coordinate LIMS data, and engage with stakeholders to maintain regulatory compliance and data integrity.