Senior Technical Writer - Quality Control

Senior Technical Writer - Quality Control Support

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Facility:
Quality

Location:

Clayton, NC, US

About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now.

FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

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 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Life & Disability Insurance

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

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

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 required
• Ability to read, write & understand complicated product documentation & standard operating procedures with attention to high-level concepts required
• Knowledgeable in core work processes & GMP concepts; knowledge of process improvement methodologies such as LEAN preferred
• Re…