Global QC Documentation Lead & Writing Expert

Biopharma Careers; Iowa (LA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Paid holidays

Job summary

Novo Nordisk Clayton QC Support seeks a skilled technical writer to design, improve and maintain QC documentation. You will serve as the English language expert for QC documents and lead, train, and mentor other writers and SMEs.

The role collaborates across departments to ensure clear, compliant documentation and supports process standardization projects. You will apply GMP knowledge, LEAN principles, and change-management skills to accelerate documentation workflows while ensuring accuracy,

Qualifications

• Bachelor's Degree or equivalent combination of education & experience required.
• Minimum five (5) years of experience in technical writing, preferably in engineering, life sciences, software, or related fields.
• Ability to read, write & understand complicated product documentation & SOPs with attention to high-level concepts.
• Knowledge of core work processes & GMP concepts; Lean experience preferred.
• Proven planning, organizing, managing & executing skills; change management experience preferred.

Responsibilities

• Design & own process for implementation of new QC documents (API, IFP, OFP) including change control & workflow approvals.
• Improve local change process for revision of QC documents for compliance & usability.
• Collaborate cross-functionally with other departments; maintain stakeholder relationships.
• Support authors with language usage, document control processes & related tools.
• Review QC documents to ensure clear, reader-friendly language.
• Participate in SOP Expert Network, Process Workshops & other document governance groups.
• Provide specialist knowledge on writing processes, document type selection, and language usage.
• Coach others in good communication & standards for operational documents.
• Support QC standardization projects and revision documentation at framework level.
• Ensure projects are completed with metrics & timelines.

Skills

Technical writing

GMP concepts

Cross-functional collaboration

Change management

Lean

Education

Bachelor's Degree or equivalent

Job description

Novo Nordisk Clayton QC Support seeks a skilled technical writer to design, improve and maintain QC documentation. You will serve as the English language expert for QC documents and lead, train, and mentor other writers and SMEs.

The role collaborates across departments to ensure clear, compliant documentation and supports process standardization projects. You will apply GMP knowledge, LEAN principles, and change-management skills to accelerate documentation workflows while ensuring accuracy,