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QSMS Documentation Area Specialist II

About the Department

At Novo Nordisk, we want to make a difference. For nearly 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 Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. 


Our Clayton, NC Injectable Finished Products (IFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at IFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging.

 

At IFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility.

 

Join Team Novo Nordisk and help us make what matters.

 

Position Purpose

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

 

Accountabilities

  • 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

 

Required Qualifications

  • AA/AS/AAS business or technical degree, or equivalent combination of experience & education
  • 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

 

Desired Qualifications

  • 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
  • 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

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work hours necessary to accomplish critical path activities
  • Able to travel internationally, up to 10% of the time
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to adjust schedule to work with colleagues in other international time zones

 

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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.

QSMS Documentation Area Specialist II

Clayton, NC
Traveling

Published on 07/23/2022

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