QA Specialist - Digital QA/IS Validation
Amgen · New Albany, OH +1 more
QualityFull-timeCompany career page
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Role summary
Amgen seeks a QA Specialist to provide quality oversight for digital systems, software applications, and automated operations at a manufacturing facility in Ohio. The role involves ensuring compliance with GMP and regulatory requirements while leading digital advancement initiatives across the organization.
What they're looking for
- Doctorate degree, or Master's with 2+ years quality/manufacturing experience
- Knowledge of computer systems validation, 21 CFR Part 11, and GMP regulations
- Experience with automated systems, electronic batch records, or quality management systems
- Proficiency in Microsoft Office suite, technical writing, and critical reasoning
- Ability to work in cross-functional teams and represent quality during regulatory inspections
- Science, computer science, or engineering degree preferred
What you'll be doing
- Lead quality oversight of design, installation, commissioning, and qualification of business software and automated systems
- Identify digital advancement opportunities and ensure quality processes are maintained during implementation
- Review and approve controlled documents including SOPs, validation protocols, and validation reports
- Collaborate across Amgen network to ensure consistency and compliance with applicable regulations
- Support quality audits and regulatory inspections; interact with regulatory agencies as needed
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.