Specialist QA

Career Category

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