Quality Improvement Area Specialist

Facility:  Manufacturing
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

Takes the lead to improve process quality on shift. Improves quality within department by solving problems, sharing solutions, and ideas with other shifts.

 

Accountabilities

  • Responsible for investigation and solution of quality problems on shift
    • Non-conformities, Unscheduled Events
  • Ensure BPR accurateness and timely approval
  • Work with process team to find preventive actions to eliminate re-occurrence of quality problems
  • Ensure compliance with training programs (IsoTrain/Eduneering) and confirm process
  • Execute process confirmation of standards utilized on shift and work with team members to improve the quality and compliance
  • Actively communicate corrective actions from investigations and confirm with all team members
  • Ensure compliance with oneDFP standards on shift
  • Perform periodic assessment of compliance (audit readiness) of shift personnel
  • Perform other duties as required

 

Desired Qualifications

  • BA/BS degree or equivalent industry experience
  • Five (5) years of manufacturing experience in a pharmaceutical environment
  • Two (2) years of Aseptic Processing experience (Aseptic Processing Department only)
  • Experience using Lean/Six Sigma methodologies and achieving sustainable process improvements
  • Knowledge of US, EU regulations and guidelines, and application of GMP’s
  • Demonstrates knowledge of adult learning methodologies and is able to use multiple methods to train and coach others
  • Excellent written communication skills, investigative writing, and computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP and novoLIMS)
  • Demonstrated experience in practical problem solving and process improvement methods
  • Ability to manage multiple tasks/deadlines and prioritize properly based on process needs. Demonstrated effectiveness in systematic follow-up

 

Physical & Other Requirements

  • Ability to work 12 hour shifts or longer, day or night
  • Ability to attain clean room gowning certification and work with hazardous materials including sanitants. (Aseptic Production)
  • Ability to work hours necessary to support shift production
  • Ability to travel internationally
  • Ability to achieve core gown certification (Aseptic Production)
  • Novo Nordisk requires all new hires to be fully vaccinated with a COVID-19 vaccine prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment

 

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.