GMP Manufacturing Documentation Engineer

BioSpace; New Albany (OH); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Health and welfare plans

Retirement and savings plan

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a documentation-focused professional to support manufacturing quality systems. The role involves drafting and revising SOPs, work instructions, protocols, technical reports, and training materials within a GMP environment.

Responsibilities include owning quality records such as deviations, CAPAs, and change controls, with collaboration across departments to maintain current GMP documentation standards.

Qualifications

• Pharma/biotech/medical device quality writing background preferred.
• Experience with SOPs, WI, protocols, technical reports and training materials.

Responsibilities

• Draft and revise GMP-compliant SOPs, WIs, protocols, reports and training material.
• Lead quality records incl. deviations, CAPAs, change controls; support QMS.

Skills

Technical writing

GMP knowledge

Quality systems

Cross-functional collaboration

Education

Doctorate or Masters with related experience

Bachelor's with related experience

Associates with extensive experience

High school diploma with 10 years experience

Job description

Amgen is seeking a documentation-focused professional to support manufacturing quality systems. The role involves drafting and revising SOPs, work instructions, protocols, technical reports, and training materials within a GMP environment.

Responsibilities include owning quality records such as deviations, CAPAs, and change controls, with collaboration across departments to maintain current GMP documentation standards.