Quality Control Analyst II - SDF
Listed on 2026-09-07
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Quality Control Analyst II - SDF
Facility:
Quality
Location:
Durham, NC, US
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.
What we offer you:
- 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.
The Position
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. Relationships Reports to Senior Manager, QC – OFP. Essential Functions 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 Author Deviations Coaching other analysts Data Trending & Tracking Ensure departmental documents are current & standardized Laboratory Equipment Validation & System support Laboratory IT System support Perform deviation & change control activities Supports Deviations Systematic Problem Solving Follow all safety and environmental requirements in the performance of duties Other accountabilities, as assigned Physical Requirements 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 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 Qualifications
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 Must demonstrate attention to detail required
Preferred Qualifications
Ability to author scientific & technical reports preferred Able to perform routine testing per SOP & GMP standards preferred Change control, deviation, trending a plus Knowledgeable in GMP & laboratory techniques preferred Serve as a subject matter expert on QC processes a plus Strong communication skills (verbal & written) preferred Troubleshooting for laboratory equipment a plus Validation &…
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