Senior Technical Writer - Quality Control Support

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

 

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

 

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

 

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.  Are you ready to realize your potential?  Join Team Novo Nordisk and help us make what matters.
 

 

The Position

Designs, improves & maintains the document creation & revision process for QC documents at site Clayton in order to support Process Responsible personnel on-site. Serves as English language technical writing expert for QC documents.  Leads, trains, coaches & mentors other QC technical writers & SME's working to establish documents.

 

Relationships

Reports to Manager, QC Support.

 

Essential Functions

• Design & own process for implementation of new API, IFP, & OFP (Local & Framework) QC documents, to include change control, document creation, assessment of training/documentation & routing/approval process
• Improve local change process for revision of QC documents, with focus on compliance with existing procedures in a way that guarantees ease of use for document owners, users & quality approvers
• Collaborates cross-functionally with other departments & maintains stakeholder relationships
• Supports authors in the writing process with language usage, document control process & related tools
• Reviews local QC documents to ensure clear & reader friendly language
• Participates in SOP Expert Network, Process Workshops, & other document governance groups
• Provides specialist knowledge on the writing process to ease understanding, choice of document type, structure & language usage of the operational documents
• Coaches others in the knowledge of good communication & standards in operational documents
• Supports &/or leads QC standardization projects as needed
• Supports the document processing of revisions to API, IFP, & OFP Framework level documents in collaboration with QC process work packages
• Ensure projects are completed with metrics & timelines realized
• Other accountabilities, as assigned

 

Physical Requirements