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QSMS Documentation Area Specialist II

Novo Nordisk
Clayton, NC
Start date
Sep 21, 2023

View more

Clinical, Clinical Medicine, Regulatory
Required Education
Associate Degree
Position Type
Full time

Job Details

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 – reimbursement up to $10,000 annually 
  • 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

Executes the document creation & revision process for various Novo Nordisk (NN) documentation in order to support Process Responsible, including processing SOPs, System Specifications, etc. & ownership of the electronic systems associated with documentation control.



Supervisor, QSMS Documentation.


Essential Functions

  • Support document owners in the writing process with language usage, document revision process, change control process & related tools
  • Review local QMS documents to ensure clear & reader friendly language
  • Collaborate cross-functionally within site
  • Provide specialist knowledge on the writing process to ease understanding, choice of document type, structure, style & language usage of the operational documents
  • Coach document owners in the knowledge of good communication & standards in operational documents
  • Support DFP standardization projects, as needed
  • Support the document processing of revisions to DFP Framework level documents in collaboration with DFP process groups
  • Develop & maintain internal & external stakeholder relationships
  • Ensure projects are completed with metrics & timelines realized
  • Proactively engaged in systematic problem solving activities collaborating on solutions regarding document processes & quality compliance
  • Proficient in Change Control process to support revision of standards
  • Ability to support & act as a backup for the Site Expert/SuperUser for novoDOCS
  • Process documents via novoDOCS or other applicable document management tools
  • Other accountabilities as assigned

    Physical Requirements

    Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.



  • AA/AS/AAS business or technical degree, or equivalent combination of experience & education
  • Minimum of three (3) years of experience in technical writing/document processing, preferably in engineering, life sciences, software or related industries
  • Ability to read, write & understand complicated product documentation & standard operating procedures with attention to high-level concepts
  • Knowledgeable in core work processes & GMP concepts
  • Knowledge of process improvement methodologies such as LEAN
  • Expert in change control [CR]
  • Highly proficient in the following software applications/tools: MS Word 2010, Adobe Acrobat Pro (latest version), Excel, PowerPoint, Visio & HTML
  • Proven expertise in planning, organizing, managing, executing, & revising the work plan & schedules for complex problems solved by cross functional teams
  • Demonstrated strong skills in change management within NN

    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.


    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.


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    Company info
    75 Hayden Avenue
    United States

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