Documentation Area Specialist II - FFEx

Novo Nordisk US

Novo Nordisk US

Clayton, NC, USA
Posted on Nov 7, 2024

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 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

Execute system administration related to document control, creation and revision for various Novo Nordisk documentation. Supports processing SOPs, System Specifications, & ownership of those documents.

Relationships

Manager

Essential Functions

  • Provide specialist knowledge on the writing process to ease understanding, choice of document type, structure, style & language usage of the operational documents
  • Review local documents to ensure clear & reader friendly language

  • Collaborate cross-functionally within site

  • Provide process administrative support for data processes

  • Coach document owners in the knowledge of good communication & standards in operational documents

  • Support standardization projects as needed

  • Develop & maintain internal & external stakeholder relationships

  • Support project completion with metrics & timelines realized

  • Proactively engaged in entry-level complexity systematic problem-solving activities collaborating on solutions regarding document processes & quality compliance

  • Proficient in Change Control process to support revision of standards

  • May support & act as a backup for the Site Expert/SuperUser for QualityDOCS as required

  • Process documents via applicable NN document management tools

  • Follow all safety and environmental requirements in the performance of duties

  • Other accountabilities, as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction

Travel Requirements

0-10% overnight travel required (% can change on a case-by-case basis based on the role.)

Development of People

Individual Contributor.

Qualifications

  • Associate’s degree in business or a technical field of study from an accredited university required
    • May consider a High School Diploma or equivalent with five (5) years of experience in technical writing or document processing required, preferably in engineering, life science or related industries required
  • Minimum of three (3) years of experience in technical writing or document processing required, preferably in engineering, life sciences, or related industries
  • Knowledgeable in GMP concepts and SAP Plant Maintenance preferred
  • Knowledge of process improvement methodologies such as LEAN preferred
  • Strong communication and organizational skills preferred
  • Highly proficient in the following software applications/tools: MS Word 2010, Adobe Acrobat Pro (latest version), Excel, PowerPoint, & Visio required
  • Proven expertise in planning, organizing, managing, executing, & revising the work plan & schedules for complex problems solved by cross functional teams required
  • Demonstrated strong skills in change management within NN preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.