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)
