Digital QA Specialist – GMP & Compliance

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen in New Albany, near Columbus, Ohio, seeks a QA Specialist to provide quality oversight for digital systems across manufacturing and warehouse operations, ensuring ALCOA++ and GMP compliance. You will lead cross-functional teams, apply problem solving to validate computer systems, and drive quality governance for electronic records and digital solutions.

Local presence at the New Albany facility is required; sponsorship for this role is not guaranteed.

Qualifications

• Doctorate degree or equivalent in science/engineering
• 2+ years of Quality and/or Manufacturing experience for Master’s
• 4+ years of Quality and/or Manufacturing experience for Bachelor's
• 8 years of Quality and/or Manufacturing experience for Associate
• 10 years of Quality and/or Manufacturing experience for High school diploma

Responsibilities

• Provide quality and compliance guidance for digital manufacturing strategies
• Identify digital advancement opportunities for quality and lead implementation
• Collaborate across Amgen Enterprise/Network for digital solutions
• Review and approve validation documents and quality records
• Ensure documentation meets GMP, Data Integrity and ALCOA++ standards
• Support audits and inspections and interact with regulatory bodies

Skills

Quality Assurance

Regulatory Compliance

GMP Knowledge

Computer Systems Validation

Data Integrity

Education

Doctorate degree

Masters degree with 2+ years QA/Manufacturing

Bachelor's degree with 4+ years QA/Manufacturing

Associate degree with 8+ years QA/Manufacturing

High school diploma with 10+ years QA/Manufacturing

Tools

Trackwise

SAP

LIMS

Vault Quality Docs

PAS-X

Job description

Amgen in New Albany, near Columbus, Ohio, seeks a QA Specialist to provide quality oversight for digital systems across manufacturing and warehouse operations, ensuring ALCOA++ and GMP compliance. You will lead cross-functional teams, apply problem solving to validate computer systems, and drive quality governance for electronic records and digital solutions.

Local presence at the New Albany facility is required; sponsorship for this role is not guaranteed.