Quality Control Analyst II - SDF

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on 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 Emerging Technologies
-Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

• 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 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• 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.

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.

Reports to Senior Manager, Quality Control – OFP.

• Accuracy & Scientific Soundness of Lab Data
• GMP Compliance of Laboratory
• Maintain testing proficiency for methods
• Timeliness of Lab Results & Investigations
• Analysis of Samples
• Author Deviations
• Coaching other analysts
• Data Trending & Tracking
• Ensure departmental documents are current & standardized
• Laboratory Equipment Validation & System support
• Laboratory IT System support
• Supports Deviations
• Systematic Problem Solving
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

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 require 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.

• Minimum of a Bachelor’s degree in Chemistry or relevant field of study from an accredited university required or an equivalent combination of education and experience
• May consider an Associate’s degree in chemistry or relevant field of study from an accredited university with a minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory
• May consider a High School Diploma or GED with a minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratory
• Minimum of three (3) years of experience in a clinical or industrial/pharmaceutical laboratory required
• Ability to author scientific & technical reports preferred
• Able to perform routine testing per SOP & GMP standards preferred
• Knowledgeable in GMP & laboratory techniques preferred
• Must demonstrate attention to detail required
• Serve as a subject matter expert on QC processes a plus
• Troubleshooting for laboratory equipment a plus
• Skills or knowledge in the following discipline:
  Chemistry Analysis of tablets including UPLC and Dissolution preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over…