Quality Assurance Area Specialist II - API

About the DepartmentAt Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do. 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 Assistance Life & 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 PositionMain duties include review of batch reports for release of API materials, minor deviations, minor change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.RelationshipsReports to Manager, QA.Essential FunctionsPerform activities related to Batch reviewReview API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPsReview & approve minor change control requests & low complex major change controlsReview & approve minor deviations & low complexity major deviationsProvide guidance to departments regarding quality & related activitiesParticipate & provide input to root-cause analysisParticipate in process confirmations & quality oversightAuthorized person according to Novo Nordisk Quality ManualOther 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.QualificationsBachelor's Degree in Life Sciences, Engineering, or related field or equivalent combination of education & work experience requiredMinimum of three (3) years of QA or related experience in the pharmaceutical or medical device industry preferredUnderstanding of cGMP manufacturing & production processes & how to apply requiredUnderstanding of the Batch review Processes preferredUnderstanding of quality management systems preferredUnderstanding of quality oversight & on floor production support preferredStrong written & verbal communication skills requiredStrong computer skills in MS Office, PowerPoint, Word, Excel, etc requiredUnderstanding of cGMPs in pharmaceutical manufacturing requiredUnderstanding of Quality & Production processes requiredGood stakeholder relations requiredCapable of prioritizing & managing workload requiredWe 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.