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