Specialist QA

Amgen; Ireland; On-site; EUR 65,000 - 95,000; Full time

Job summary

Amgen in Ireland is seeking a Disposition Manager within the Global Supply Quality team to oversee batch disposition activities in line with Amgen standards.

You will manage quality records, deviations, investigations and supplier change controls, ensuring timely closure and compliant documentation across GMP/GDP processes. Strong cross-functional collaboration and excellent technical writing are essential.

Qualifications

• Master’s degree or equivalent in a related field.
• Bachelor’s degree with 2+ years experience in QA/pharma.
• Associate’s degree with 6+ years experience in QA/pharma.
• High school diploma with 8+ years related experience.

Responsibilities

• Act as disposition manager ensuring batch disposition aligns with Amgen standards.
• Close quality records and deviations; manage investigations.
• Initiate quality records for supplier changes.
• Collaborate with Complaints to review assessments and comments.
• Provide data to networks to support QMS processes.
• Prepare, review and approve GMP/GDP docs per regulatory requirements.
• Participate in quality initiatives and projects.
• Communicate with stakeholders to align quality objectives and compliance needs.

Skills

SAP

LIMS

Supply chain basics

GMP software

MS Office

Multitasking

Technical writing

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

Veeva

TrackWise

Job description

In this role you will be part of Amgen’s Global Supply Quality team supporting oversight and maintenance of contract manufacturers. In the role you will act as a disposition manager ensuring that batch disposition activities are completed in line with Amgen standards.

Key Responsibilities

• Act as disposition manager ensuring that batch disposition activities are completed in line with Amgen standards
• Manage and drive Quality records to closure including deviation records, investigation reports
• Initiate Quality records for supplier related changes.
• Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
• Provide data to the networks to support Quality Management Processes
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Take part in operational and quality improvement initiatives, programs, and projects.
• Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.

Competencies/Skills:

• Deep knowledge of SAP and LIMS systems
• Basic understanding of supply chain and logistics processes.
• Experience with GMP software (Veeva, TrackWise).
• Proficiency in MS Office and comfort with computer-based systems.
• Ability to multitask in a dynamic environment.
• Demonstrated ability to work independently and deliver right first-time results
• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills

Basic Qualifications:

• Master’s degree OR
• Bachelor’s degree & 2 years of directly related experience OR
• Associate’s degree & 6 years of directly related experience OR
• High school diploma / GED & 8 years of directly related experience

Preferred Qualifications

• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• cGMP Experience
• Able to successfully manage workload to timelines
• Familiarity with basic project management tools
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)