Specialist QA
About The Position
The Quality Assurance (QA) Technical Services Specialist provides quality oversight for key quality processes, including deviations, corrective actions, and change controls, and serves as a quality partner to non-manufacturing functions such as Process Development, Information Systems, and Quality Control. The role supports complex investigations and site strategic priorities, and may include cross-training or project-specific assignments such as continuous improvement initiatives. The Specialist is expected to work proactively and autonomously, making risk-based decisions to uphold and improve the quality management system. The position provides advice and oversight to ensure products are manufactured, tested, stored, and distributed in accordance with current good manufacturing procedures. It serves as the ARI subject matter expert for deviation, CAPA, change control, and risk management processes, monitoring quality-system performance, providing technical and procedural expertise, and supporting initiatives that improve compliance, effectiveness, and operational efficiency. The Specialist reviews and approves GMP processes and documentation, evaluates quality impacts of changes, advises on investigations and corrective actions, assesses risks, supports project teams, and helps maintain inspection readiness. The role also contributes to continuous improvement and sharing best practices across the Amgen network. This is an on-site role with flexibility based on business and team needs.
Requirements
- High school diploma or GED and 10 years of experience in Quality, Manufacturing, Process Development, or Process Engineering; or an associate’s degree and 8 years of relevant experience; or a bachelor’s degree and 4 years of relevant experience; or a master’s degree and 2 years of relevant experience; or a doctorate degree.
- Ability to work proactively and autonomously and make risk-based decisions.
- Working understanding of applicable requirements and best practices.
Nice To Haves
- Expert quality and technical support experience resolving complex contamination-control investigations and experience with environmental monitoring programs.
- Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs), including quality-system integration, supplier readiness, risk assessments, change-control oversight, and alignment with regulatory and inspection-readiness expectations across global networks.
- Demonstrated problem-solving abilities and experience managing deviations, change controls, CAPA, and 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.
Responsibilities
- 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 for deviation, CAPA, change control, and risk management processes.
- Monitor quality management system process health and performance, provide technical and procedural expertise, and lead or support strategic projects and continuous improvement initiatives.
- Develop and maintain a working understanding of applicable requirements and best practices.
- Provide risk-based quality advice on deviation investigation strategies and implementation of corrective actions and change controls.
- Manage quality processes and ensure changes are evaluated for quality impact and implemented according to Amgen processes and procedures.
- Review and approve GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, SOPs, 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 functions and processes.
- Implement proactive measures to prevent potential issues and maintain inspection readiness.
- Maintain relationships within the Amgen network to benchmark and share best practices.
- Drive site- and network-level continuous improvement initiatives.
Benefits
- Health and welfare plans for staff and eligible dependents
- Financial plans with opportunities to save toward retirement or other goals
- Work/life balance and career development opportunities
- Retirement and Savings Plan with generous company contributions
- Group medical, dental, and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
