Specialist QA

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

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)