QA Specialist - Digital QA/IS Validation

Amgen’s mission is to serve patients living with serious illnesses. Since 1980, the company has pioneered biotech innovations across Oncology, Inflammation, General Medicine, and Rare Disease, delivering medicines that improve and extend lives. The Quality Assurance Specialist will support the Advanced Assembly and Final Product Operations facility in New Albany, Ohio, providing quality oversight for the design, installation, commissioning, qualification, and digital operations of manufacturing and warehouse systems.

Responsibilities

• Provide quality and compliance expertise and guidance for design, installation, commissioning, qualification, and process qualification of digital manufacturing strategies.
• Identify digital advancement opportunities, lead their implementation, and ensure adherence to quality processes.
• Collaborate cross‑functionally and across the Amgen enterprise/network to implement digital advancements in line with procedures and regulations.
• Partner with other facilities to ensure consistent implementation of digital solutions, standard processes, and continuous improvement.
• Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, and Validation Reports.
• Ensure all activities and documentation comply with applicable regulations and Amgen requirements (GMP, GDocP, Data Integrity, Safety, Controls).
• Own quality‑related SOPs, work instructions, and forms.
• Validate relevant processes, equipment, and systems, maintaining current validation status.
• Support and represent Quality during audits and inspections; interact with regulatory agencies as needed.
• Support Lean Transformation and Operational Excellence initiatives.

Basic Qualifications

• Doctorate degree OR Master’s degree + 2 years of Quality and/or Manufacturing experience OR Bachelor’s degree + 4 years of Quality and/or Manufacturing experience OR Associate’s degree + 8 years of Quality and/or Manufacturing experience OR High school diploma/GED + 10 years of Quality and/or Manufacturing experience.

Preferred Qualifications

• Master’s or Bachelor’s degree in Science, Computer Science, Engineering, or a related field.
• 5 years of experience in GMP operations, ICH, 21 CFR Part 11, EU Annex 11, or similarly regulated industry.
• Affinity for digital innovation, data science, and quality engineering.
• Experience with computer systems validation and automated systems (Electronic Batch Record, Electronic Quality Management System, IIoT, Digital Control Tower, Advanced Analytics, etc.).
• Proficiency with Microsoft Excel, Word, PowerPoint, Project, Access, Visio; Adobe Acrobat; database platforms; knowledge of TrackWise, PAS‑X, Vault Quality Docs, SAP, LIMS, etc.
• Experience reviewing and approving validation documentation.
• Skilled technical writing and critical reasoning.
• Excellent written and verbal communication; ability to work in a matrixed team environment.
• Strong attention to detail and accuracy in GMP documentation.
• Ability to work autonomously, provide updates to senior management, and identify potential issues.
• Demonstrated problem‑solving ability and experience managing root‑cause analysis/deviation investigations.
• Experience with dynamic cross‑functional teams and decision‑making.
• Strong organizational skills and ability to follow assignments through to completion.
• Leadership capabilities and experience applying GMP requirements operationally.
• Self‑starter who can interact independently with various organizational levels.

Benefits

• Comprehensive employee benefits package, including health, dental, vision, life, and disability insurance.
• Retirement and savings plans with generous company contributions.
• Flexible spending accounts.
• Discretionary annual bonus program (or sales‑based incentive plan for field sales).
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models, including remote and hybrid arrangements where possible.
• Career development opportunities and support for professional and personal growth.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on factors such as relevant skills, experience, and qualifications.