Quality Compliance Specialist - GMP & SAP/LIMS

Amgen; Dublin; On-site; EUR 60,000 - 90,000; Full time

Job summary

Amgen is seeking a quality professional in Ireland to act as disposition manager and drive batch disposition in line with Amgen standards. You will manage quality records, initiate supplier-related changes, and collaborate with the Complaints team on assessments and investigations.

The role requires strong communication and technical writing skills, experience with SAP/LIMS and GMP software, and the ability to deliver right-first-time results in a matrixed environment.

Qualifications

• Master’s degree or equivalent with related experience
• Bachelor’s with 2+ years related experience; Associate with 6 years; HS diploma with 8 years
• Experience in biotech/pharma quality/manufacturing is preferred

Responsibilities

• Act as disposition manager ensuring batch disposition activities align with Amgen standards
• Manage and drive Quality records to closure including deviation records and investigation reports
• Initiate Quality records for supplier-related changes
• Collaborate with Complaints team to request assessments and review complaint reports
• Provide data to networks to support Quality Management Processes
• Prepare, review and approve SOPs and other cGMP/GDP documentation
• Take part in operational and quality improvement initiatives and projects
• Communicate with stakeholders to align on quality objectives and compliance needs

Skills

Strong communication

Multitasking

Independent worker

Technical writing

MS Office proficiency

Education

Master’s degree

Bachelor’s degree & 2 years of directly related experience

Associate’s degree & 6 years of directly related experience

High school diploma / GED & 8 years of directly related experience

Tools

SAP

LIMS

Veeva

TrackWise

MS Office

Job description

Amgen is seeking a quality professional in Ireland to act as disposition manager and drive batch disposition in line with Amgen standards. You will manage quality records, initiate supplier-related changes, and collaborate with the Complaints team on assessments and investigations.

The role requires strong communication and technical writing skills, experience with SAP/LIMS and GMP software, and the ability to deliver right-first-time results in a matrixed environment.