Specialist QA

What you will do

The Quality Assurance (QA) Technical Services Specialist is a critical role for the ARI site. The QA Technical Services team provides quality oversight for the execution of key processes such as deviations, corrective actions, and change controls; as well as general quality partner support for functions outside of manufacturing (including PD, IS, and QC). Because the function is engaged with complex investigations and delivery of site strategic priorities, the role offers the opportunity to engage broadly across the ARI site and within the network. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement initiatives, therefore, the ideal candidate will have demonstrated competencies across a broad range of quality-related disciplines. This role demands a proactive and autonomous professional, capable of making risk-based decisions to uphold and improve our quality management system.

Key Responsibilities include:

• Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
• Serve as the ARI Subject Matter Expert (SME) for Deviation, CAPA, Change Control and risk management processes, responsible for monitoring QMS process health and performance, driving continuous improvement initiatives, providing technical and procedural expertise, and leading or supporting strategic projects to enhance compliance, effectiveness, and operational efficiency.
• Develop and maintain a working understanding of applicable requirements and best practices.
• Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control.
• Manage the quality processes, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow Amgen’s processes and procedures.
• Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.
• Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
• Independently assess and prioritize quality risks across various functions and processes.
• Implement proactive measures to prevent potential issues and ensure a state of inspection readiness.
• Maintain relationships within the Amgen network to help benchmark and share best practices.
• Drive continuous improvement initiatives at the site and network level to create value for the business.

Basic Qualifications

• High school diploma / GED & 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Associate’s degree & 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Bachelor’s degree & 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Master’s degree & 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Doctorate degree

Preferred Qualifications

• Deliver expert quality and technical support for the resolution of complex contamination control investigations and experience with environmental monitoring programs.
• Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs), ensuring robust quality system integration, supplier readiness, risk assessments, change control oversight, and seamless alignment with regulatory and inspection readiness expectations across global networks.
• Demonstrated abilities in problem solving, and experience managing deviation/change control/CAPA & risk management.
• Excellent written and verbal communication skills with cross functional teams, network, and management.
• Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.
• Experience with Regulatory inspections.