Quality Control Analyst III

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  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 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.

Relationships Reports to Manager.

Essential Functions Ensure accuracy & scientific soundness of lab data Endure environnemental compliance

Support & ensure GMP Laboratory Compliance Maintain testing proficiency for methods

Ensure timeliness of lab results & investigations

Perform analysis of samples

Author deviations

Coach other analysts

Perform data trending & tracking

Develop process competence across IFP/APIDrive process improvement for Site QCEnsure 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

Perform deviation & change control activities

Support other NNPILP sites when relevant

Support deviations

Participate in Systematic Problem Solving Follow all safety & 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 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 Qualifications 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

Demonstrate attention to detail required

Serve as a subject matter expert on QC processes required

Strong communication skills (verbal & written) 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

Preferred Qualifications Advanced level of troubleshooting for laboratory equipment preferred

Validation & technical transfer…