Specialist QA

Amgen; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

Amgen's Global Supply Quality team is seeking a Disposition Manager to oversee batch disposition activities, ensuring alignment with Amgen standards.

You will drive quality records closure, collaborate with complaints, prepare SOPs, and support cGXP documentation while operating in a matrixed, fast-paced biotech environment. This role requires strong communication, independent work, and a proven ability to deliver high-quality results on time.

Qualifications

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

Responsibilities

• Act as disposition manager ensuring batch disposition aligns with Amgen standards.
• Manage quality records to closure including deviations and investigations.
• Initiate quality records for supplier-related changes.
• Collaborate with Complaints to review and address reports.
• Provide data to networks to support Quality Management Processes.
• Prepare, review and approve SOPs and cGMP/GDP documentation.
• Participate in quality improvement initiatives and projects.
• Communicate with stakeholders to ensure alignment on quality objectives.

Skills

SAP

LIMS systems

GMP software

MS Office

Independent work

Strong communication

Technical writing

Education

Master's degree

Bachelor's degree + 2 years experience

Associate's degree + 6 years experience

High school diploma / GED + 8 years 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)