QC Regulatory & Stability Area Specialist

Facility:  Quality
Location: 

Clayton, NC, US

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

Responsible for supporting the stability & retain programs for QC site Clayton. Support process & drive improvement activities based on process performance, event response & process confirmation. Ensures audit readiness & shares ideas & solutions with other departments & sites.

 

Accountabilities

  • Responsible for preparing & updating stability protocols & reports
  • Trend stability data & initiate trend investigations
  • Responsible for providing stability & retain reports to corporate for annual product reviews
  • Track & ensure stability testing is completed on time
  • Write stability documents to support regulatory submission for new products
  • Write stability documents for all other regulatory requests
  • Support LIMS builds & training for QC site Clayton
  • Maintain stability & reference sample inventory (storage & discard of samples)
  • Stability representative during audits/inspections
  • Project team member for new product transfers
  • Other duties as assigned

 

Required Qualifications

  • BS/BA in Chemistry or related scientific field preferred or equivalent education & experience

 

Desired Qualifications

  • Minimum of two (2) years of experience with stability programs &/or regulatory relevant experience
  • Strong communication skills (verbal & written) & the ability to author scientific & technical reports
  • Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications
  • Ability to control all aspects of the stability & retain programs

 

Physical & Other Requirements

  • Occasionally moves equipment &/or supplies weighing up to 50 pounds, using various body positions
  • Ability to perform close precision work with hands
  • Ability to remain in a stationary position up to 50% of the time
  • Corrected vision to 20/30 & ability to see all colors
  • Occasionally ascends/descends a ladder to take samples
  • Occasionally works around odorous &/or hazardous materials

 

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.