Manufacturing Documentation and Quality Systems Specialist

BioSpace; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen is seeking a document-focused professional to support the manufacturing team with SOPs, WI, protocols, and reports within a GMP environment. This role will own quality records such as deviations, CAPAs, and change controls, while providing SME-level technical support and ensuring alignment with the Quality Management System.

Responsibilities include coordinating with multiple departments to update training materials, document changes, and drive continuous process improvements.

Qualifications

• Doctorate degree or equivalent as required for role in pharmaceutical manufacturing.
• Masters, Bachelors, Associates, or High school path with 2/4/8/10 years in Engineering, Manufacturing, Packaging or Quality in pharma/biotech.
• Experience with GMP pharma/biotech industry and strong technical writing background.

Responsibilities

• Develop, review, and update SOPs, WI, risk assessments, protocols and reports for the manufacturing team.
• Generate, own, and provide SME to Quality System records such as deviations, CAPA and change controls.
• Provide technical and clerical support to the manufacturing team in documentation preparation and data tracking.
• Liaise with manufacturing and cross-functional departments for documentation changes.
• Collaborate on training documentation for manufacturing staff.
• Support process owners and continuous process improvement projects.
• Help reduce document turnaround times and ensure schedule adherence.
• Develop protocols to support change controls, deviations and troubleshooting with SMEs.
• Coordinate with QA to maintain GMP standards in current operating systems.

Skills

GMP pharma experience

Technical writing

Problem solving

Cross-functional collaboration

Communication skills

Education

Doctorate degree

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

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

Associates degree in Engineering/Manufacturing/Packaging/Quality

High school diploma / GED in Engineering/Manufacturing/Quality

Tools

QMS

Job description

Amgen is seeking a document-focused professional to support the manufacturing team with SOPs, WI, protocols, and reports within a GMP environment. This role will own quality records such as deviations, CAPAs, and change controls, while providing SME-level technical support and ensuring alignment with the Quality Management System.

Responsibilities include coordinating with multiple departments to update training materials, document changes, and drive continuous process improvements.