Quality Control Analyst III

About the DepartmentFor 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 positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee Referral AwardsAt 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 PositionPerform & 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.RelationshipsReports to Manager.Essential FunctionsEnsure accuracy & scientific soundness of lab dataEndure environnemental complianceSupport & ensure GMP Laboratory ComplianceMaintain testing proficiency for methodsEnsure timeliness of lab results & investigationsPerform analysis of samplesAuthor deviationsCoach other analystsPerform data trending & trackingDevelop process competence across IFP/APIDrive process improvement for Site QCEnsure all Analyst testing of samples is complete, as neededEnsure departmental documents are current & standardizedPerform Laboratory Equipment Validation & System supportProvide Laboratory IT System supportLeverage solutions to other NNPILP sitesPerform deviation & change control activitiesSupport other NNPILP sites when relevantSupport deviationsParticipate in Systematic Problem SolvingFollow all safety & environmental requirements in the performance of dutiesOther accountabilities, as assignedPhysical RequirementsMoves 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 QualificationsBachelor’s Degree from an accredited university requiredMay consider an Associate’s Degree from an accredited university with seven (7) years of relevant experience in a clinical or industrial/pharmaceutical laboratory requiredFive (5) years of experience in a clinical or industrial/pharmaceutical laboratory requiredAbility to author scientific & technical reports requiredAble to perform routine testing per SOP & GMP standards requiredAdvance level knowledge in GMP & laboratory techniques requiredDemonstrate attention to detail requiredServe as a subject matter expert on QC processes requiredStrong communication skills (verbal & written) requiredSkills 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) requiredPreferred QualificationsAdvanced level of troubleshooting for laboratory equipment preferredValidation & technical transfer experience preferredProject Management experience is a plusChange control, deviation, trending preferredWe 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 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.