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Quality Control Analyst - OFP

Facility:  Quality
Location: 

Durham, NC, US

About the Department

For almost 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes. Being part of Novo Nordisk, we offer our employees life-changing careers and the opportunity to improve the quality of life for millions of people around the world.

 

Working at our Oral Finished Products (OFP) tableting facility in Durham, NC you will help meet the growing demand for our treatments, specifically supporting innovative oral treatments for patients with type 2 diabetes.

 

Our facility sits on 194,000 square feet of state-of-the-art equipment and we currently employ approximately 65 passionate and committed employees working across Bulk Production, Packaging, Warehouse, Business Support, QC and QA. 

 

Join OFP Site Durham and help us make a difference for the people who rely on our products every day. Here, you will work with the best manufacturing professionals in the industry. Are you ready for a life-changing career?

We are open to hiring at Level I or II for this role.

Position Purpose

Perform & review analysis of in-process, release & stability samples in accordance with cGMP, site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines.

 

Accountabilities

  • Accuracy & Scientific Soundness of Lab Data
  • Environmental Compliance
  • GMP Compliance of Laboratory
  • Maintain testing proficiency for methods
  • Timeliness of Lab Results & Investigations
  • Analysis of Samples
  • Supports Deviations
  • Other accountabilities, as assigned

 

Desired Qualifications

  • BA/BS in a science or equivalent combination of experience & education
  • Minimum one (1) year of experience in a clinical or industrial/pharmaceutical laboratory
  • Ability to author scientific & technical reports
  • Able to perform routine testing per SOP & GMP standards
  • Basic troubleshooting for laboratory equipment
  • Knowledgeable in GMP & laboratory techniques
  • Must demonstrate attention to detail
  • Strong communication skills (verbal & written)
  • Skills or knowledge in the following discipline: Chemistry Analysis of tablets including UPLC and Dissolution
  • Ability to execute testing according to a structured plan

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility using various body positions
  • Able to do close precision work with their hands
  • Must be able to remain in a stationary position 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 and/or hazardous materials
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation

 

Novo Nordisk requires all employees to be fully vaccinated with a COVID-19 vaccine by December 8, 2021.  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.

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. 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.