Manufacturing Documentation Specialist (GMP/QA)

Amgen; New Albany (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, vision benefits

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Amgen seeks a highly qualified professional to support manufacturing documentation within a GMP environment. You will draft and revise SOPs, WI, protocols, and reports, while leading quality records and facilitating change controls in collaboration with multiple teams.

This role emphasizes strong writing, troubleshooting, and proactive prioritization to ensure timely, accurate documentation and training materials across manufacturing operations.

Qualifications

• Doctorate or equivalent in engineering, manufacturing or quality related field.
• Advanced degrees with pharma/biotech experience preferred.
• Experience in GMP pharma/biotech environments.
• Strong writing and documentation skills.

Responsibilities

• Draft and revise SOPs, WI, protocols, reports in GMP environment.
• Lead quality records: deviations, CAPA, change controls, QMS support.
• Assist with data collation and preparation of technical documents.
• Collaborate with cross-functional teams on documentation changes.
• Support training documentation for manufacturing staff.
• Contribute to continuous process improvement and troubleshooting.

Skills

Troubleshooting

Problem-solving

Communication

Prioritization

Education

Doctorate degree

Master’s degree + 2 years experience in Eng/Manufacturing/Packaging/Quality

Bachelor’s degree + 4 years experience in Eng/Manufacturing/Packaging/Quality

Associate’s degree + 8 years experience in Eng/Manufacturing/Packaging/Quality

High school diploma / GED + 10 years experience in Eng/Manufacturing/Packaging/Quality

Job description

Amgen seeks a highly qualified professional to support manufacturing documentation within a GMP environment. You will draft and revise SOPs, WI, protocols, and reports, while leading quality records and facilitating change controls in collaboration with multiple teams.

This role emphasizes strong writing, troubleshooting, and proactive prioritization to ensure timely, accurate documentation and training materials across manufacturing operations.