GMP Documentation & Quality Specialist

Amgen Inc. (IR); New Albany (OH); On-site; USD 108,000 - 146,000; Full time

Job summary

Amgen Inc. in Ohio is seeking an experienced documentation professional to support GMP manufacturing. You will develop, review, and update SOPs, WIs, and protocols, manage deviations, CAPA and change controls, and provide clerical support for document control.

You’ll liaise with cross-functional teams to implement changes and drive training documentation and continuous improvement. The role emphasizes accurate record keeping, timely processing, and maintaining current GMP standards in a

Qualifications

• Doctorate or Master’s with 2 years in Eng, Manufacturing, Packaging or Quality in pharma/biotech.
• Bachelor’s with 4 years in Eng, Manufacturing, Packaging or Quality in pharma/biotech.
• Associate’s with 8 years in Eng, Manufacturing, Packaging or Quality.
• High school diploma / GED with 10 years in Eng, Manufacturing, Packaging or Quality.

Responsibilities

• Develop, review, and update SOPs, WIs, protocols & reports for manufacturing.
• Generate, own, and provide subject matter expertise to records like deviations, CAPA and change controls.
• Provide technical and clerical support to the manufacturing team for documentation and data tracking.
• Liaise with manufacturing and cross functional teams on documentation changes.
• Collaborate with departments to support training documentation and continuous improvement.
• Support process owners and participate in troubleshooting and ongoing improvements.
• Help reduce document turnaround times and keep schedules current.

Education

Doctorate degree

Master’s degree with 2 years in Eng, Manufacturing, Packaging or Quality

Bachelor’s degree with 4 years in Eng, Manufacturing, Packaging or Quality

Associate’s degree with 8 years in Eng, Manufacturing, Packaging or Quality

High school diploma / GED with 10 years in Eng, Manufacturing, Packaging or Quality

Job description

Amgen Inc. in Ohio is seeking an experienced documentation professional to support GMP manufacturing. You will develop, review, and update SOPs, WIs, and protocols, manage deviations, CAPA and change controls, and provide clerical support for document control.

You’ll liaise with cross-functional teams to implement changes and drive training documentation and continuous improvement. The role emphasizes accurate record keeping, timely processing, and maintaining current GMP standards in a