QC Documentation Lead & Process Standards Coach

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

14 paid holidays

Health insurance

Dental insurance

Vision insurance (effective day one)

401(k) with company match

Parental & family leave

Life & disability insurance

Employee referral awards

Tuition assistance

Free Novo Nordisk products

Job summary

Novo Nordisk in Clayton, NC seeks an experienced QC Documentation Specialist to design, improve, and maintain QC documents. You will serve as the English language technical writing expert for QC materials and lead/coaching others in writing standards.

The role requires a Bachelor's degree and 5+ years in technical writing within life sciences or related fields. Strong collaboration across departments is essential with a focus on compliant, reader-friendly documentation.

Qualifications

• Bachelor's Degree or equivalent combination of education & experience.
• 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 high-level concepts.
• Knowledgeable in core work processes & GMP concepts; knowledge of LEAN preferred.
• Proven planning/organizing, managing, executing skills; change management experience preferred.

Responsibilities

• Design & own process for implementation of new API, IFP, & OFP QC documents, including change control, document creation, training documentation, and routing/approval.
• Improve local change process for revision of QC documents with emphasis on compliance and ease of use.
• Collaborates cross-functionally with other departments and maintains stakeholder relationships.
• Supports authors in the writing process with language usage, document control processes & tools.
• Reviews local QC documents to ensure clear & reader-friendly language.
• Participates in SOP Expert Network, Process Workshops, and other document governance groups.
• Provides specialist knowledge on writing processes to aid document type selection and language usage.

Skills

Technical writing

GMP knowledge

Change management

Documentation control

Cross-functional collaboration

Education

Bachelor's degree

Job description

Novo Nordisk in Clayton, NC seeks an experienced QC Documentation Specialist to design, improve, and maintain QC documents. You will serve as the English language technical writing expert for QC materials and lead/coaching others in writing standards.

The role requires a Bachelor's degree and 5+ years in technical writing within life sciences or related fields. Strong collaboration across departments is essential with a focus on compliant, reader-friendly documentation.