Quality Control Analyst - SDF; Durham, NC,

About the Department

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

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, QC – OFP.

• 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
• 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 required corrected vision to 20/25 based on role.
• May require colour 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 one (1) year of experience in a clinical or industrial/pharmaceutical laboratory required
• Must demonstrate attention to detail required

• Ability to author scientific & technical reports a plus
• Able to perform routine testing per SOP & GMP standards a plus
• Basic troubleshooting for laboratory equipment a plus
• Knowledgeable in GMP & laboratory techniques a plus
• Strong communication skills (verbal & written) a plus
• Skills or knowledge in the following discipline:
  Chemistry Analysis of tablets including UPLC and Dissolution desired

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

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