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
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Act as disposition manager ensuring that batch disposition activities are completed in line with Amgen standards
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Manage and drive Quality records to closure including deviation records, investigation reports
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Initiate Quality records for supplier related changes.
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Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
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Provide data to the networks to support Quality Management Processes
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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.
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Take part in operational and quality improvement initiatives, programs, and projects.
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Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.
Competencies/Skills:
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Deep knowledge of SAP and LIMS systems
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Basic understanding of supply chain and logistics processes.
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Experience with GMP software (Veeva, TrackWise).
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Proficiency in MS Office and comfort with computer-based systems.
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Ability to multitask in a dynamic environment.
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Demonstrated ability to work independently and deliver right first-time results
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Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills
Basic Qualifications:
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Master’s degree OR
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Bachelor’s degree & 2 years of directly related experience OR
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Associate’s degree & 6 years of directly related experience OR
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High school diploma / GED & 8 years of directly related experience
Preferred Qualifications:
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5+ years of quality and manufacturing experience in biotech or pharmaceutical industry
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Bachelor’s Degree in a Science Field
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cGMP Experience
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Able to successfully manage workload to timelines
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Familiarity with basic project management tools
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Demonstrated ability to consistently deliver on-time, and high-quality results
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Ability to operate in a matrixed or team environment
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Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
