QA & Digital Validation Specialist — Remote/Hybrid

BioSpace; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible work models

Competitive benefits

Career development

Job summary

Amgen seeks a QA Specialist to provide quality oversight for digital manufacturing at the New Albany site, near Columbus, Ohio. You will guide design, installation, commissioning, and qualification of software and automated systems, ensuring GMP and data integrity across manufacturing and warehouse operations.

You will collaborate with cross-functional teams, maintain controlled documents, and support audits and inspections while advancing digital quality initiatives.

Qualifications

• Doctorate, Masters, Bachelors, or Associates with related QC/Manufacturing experience.
• Strong GMP/ICH/21 CFR Part 11 knowledge preferred.
• Experience in validation and qualification activities.
• Excellent written and verbal communication in a regulated environment.

Responsibilities

• Provide quality and compliance guidance for digital manufacturing systems.
• Lead process qualification and validation of software and automated systems.
• Ensure documents and SOPs meet GMP requirements and are up to date.
• Support audits, inspections, and cross-functional implementation of digital solutions.

Skills

Quality assurance

Regulatory compliance

Documentation control

Cross-functional collaboration

Education

Doctorate degree

Masters degree + 2 years QC/Manufacturing experience

Bachelors degree + 4 years QC/Manufacturing experience

Associates degree + 8 years QC/Manufacturing experience

High school diploma / GED + 10 years QC/Manufacturing experience

Tools

Trackwise

PAS-X

Vault Quality Docs

SAP

LIMS

Job description

Amgen seeks a QA Specialist to provide quality oversight for digital manufacturing at the New Albany site, near Columbus, Ohio. You will guide design, installation, commissioning, and qualification of software and automated systems, ensuring GMP and data integrity across manufacturing and warehouse operations.

You will collaborate with cross-functional teams, maintain controlled documents, and support audits and inspections while advancing digital quality initiatives.