GMP Manufacturing Documentation Specialist

Amgen; New Albany (IN); On-site; USD 108,000 - 146,000; Full time

Job summary

Amgen in New Albany, IN, is seeking a qualified professional to support the manufacturing team by drafting and revising SOPs, work instructions, protocols, technical reports, and training materials within a GMP environment.

You will lead quality records such as deviations and CAPAs, coordinate with cross-functional teams, and ensure documentation remains current, accurate, and audit-ready to help deliver medicines to patients.

Qualifications

• Doctorate degree with pharmaceutical/biotech experience.
• Master’s with 2 years in Engineering, Manufacturing, Packaging or Quality.
• Bachelor’s with 4 years in Engineering, Manufacturing, Packaging or Quality.
• Associate’s with 8 years in Engineering, Manufacturing, Packaging or Quality.
• High school diploma with 10 years in Engineering, Manufacturing, Packaging or Quality.

Responsibilities

• Draft and revise SOPs, WIs, protocols, and reports in GMP environment.
• Lead deviations, CAPAs, and change controls within QMS.
• Prepare documentation and track technical documents with data collocation.
• Collaborate with manufacturing and cross-functional teams on documentation changes.
• Support training documentation for manufacturing staff.
• Assist process owners in continuous improvement and troubleshooting.

Skills

Technical writing

Documentation

Troubleshooting

Cross-functional collaboration

Education

Doctorate degree

Master’s degree in Engineering/Manufacturing/Packaging/Quality

Bachelor’s degree in Engineering/Manufacturing/Packaging/Quality

Associate’s degree

High school diploma / GED

Tools

GMP documentation systems

Quality Management System (QMS)

Job description

Amgen in New Albany, IN, is seeking a qualified professional to support the manufacturing team by drafting and revising SOPs, work instructions, protocols, technical reports, and training materials within a GMP environment.

You will lead quality records such as deviations and CAPAs, coordinate with cross-functional teams, and ensure documentation remains current, accurate, and audit-ready to help deliver medicines to patients.