GMP Manufacturing Documentation Specialist

Amgen SA; New Albany (OH); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based incentives

Discretionary bonus program

Flexible work options

Job summary

Amgen is seeking a qualified professional to support the manufacturing team by drafting and revising GMP documents, SOPs, WI, and protocols. You will ensure quality records, deviations, CAPA, and change controls are tracked and controlled within the QMS.

Collaboration across departments is essential to maintain current documentation and support training materials. Preferred candidates will have strong technical writing skills, GMP experience in pharma/biotech, and the ability to translate

Qualifications

• Experience writing and revising SOPs, WI, protocols, and technical reports.
• Strong knowledge of GMP and QA systems.
• Ability to translate technical content into manufacturing instructions.

Responsibilities

• Develop, review, and update GMP documents for manufacturing.
• Lead deviations, CAPA, and change control records with SMEs.
• Collaborate with cross-functional teams to support training documentation.

Skills

GMP Documentation

Technical Writing

CAPA

Change Control

QA Liaison

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

SOPs & WI authoring

Job description

Amgen is seeking a qualified professional to support the manufacturing team by drafting and revising GMP documents, SOPs, WI, and protocols. You will ensure quality records, deviations, CAPA, and change controls are tracked and controlled within the QMS.

Collaboration across departments is essential to maintain current documentation and support training materials. Preferred candidates will have strong technical writing skills, GMP experience in pharma/biotech, and the ability to translate