Job Details

Quality

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)

Salary Range

67,813.85 EUR - 91,748.15 EUR