Specialist QA

### **Career Category** Quality ### **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) . **Salary Range** 67,813.85 EUR - 91,748.15 EUR