Quality Control Analyst III

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 14weeks 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 of API and/or filled product in accordance with cGMP, site & corporate policies & procedures. Transfer of technology & processes in accordance with relevant project plans & timelines. Provide leadership for other analysts as they execute their daily tasks.

Reports to Manager.

• Ensure accuracy & scientific soundness of lab data
• Support & ensure GMP Laboratory Compliance
• Maintain testing proficiency for methods
• Ensure timeliness of lab results & investigations
• Perform analysis of samples
• Coach other analysts
• Perform data trending & tracking
• Develop process competence across IFP/API
• Drive process improvement for Site QC
• Ensure all Analyst testing of samples is complete, as needed
• Ensure departmental documents are current & standardized
• Perform Laboratory Equipment Validation & System support
• Provide Laboratory IT System support
• Leverage solutions to other NNPILP sites
• Support other NNPILP sites when relevant
• Participate in Systematic Problem Solving
• Follow all safety & 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.

• Bachelor’s Degree from an accredited university required
• May consider an Associate’s Degree from an accredited university with seven (7) years of relevant experience in a clinical or industrial/pharmaceutical laboratory required
• Five (5) years of experience in a clinical or industrial/pharmaceutical laboratory required
• Ability to author scientific & technical reports required
• Able to perform routine testing per SOP & GMP standards required
• Advance level knowledge in GMP & laboratory techniques required
• Serve as a subject matter expert on QC processes required
• Skills or knowledge in one of the following disciplines:
  Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, PH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis) required

• Advanced…