Quality Control Validation Area Specialist I Position Available In Johnston, North Carolina

Quality Control Validation Area Specialist I
Employer
Novo Nordisk
Location
Clayton, NC
Start date
Jun 19, 2025
categoriesView less categories Job Details
Company
Job Details About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and 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 Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic “fill and finish” site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, 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 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 Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables. Relationships Reports to Manager. Essential Functions Accuracy & compliance of validation & equipment recordsValidation responsible for QC equipment & instrumentationIdentify & handle deviations per proper appropriate proceduresMaintain good standing with stakeholders through engagement & positive cooperationPerform & oversee change control activities for QC equipment & systemsFollow all safety and environmental requirements in the performance of dutiesOther 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 color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. Qualifications Bachelor’s Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university requiredMay consider Associate’s Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of four (4) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field requiredMinimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field requiredExperience in writing & executing validation protocols preferredExperience in managing projects preferredExperience with electronic validation systems (TIMS) and SAP PM and QM module a plusWorking knowledge of GMPs requiredAbility to act as project manager driving & implementing equipment projects requiredDemonstrated ability to write & present technical/scientific documents & reports preferred Understanding of QC equipment/systems, end user functionality & life-cycle management a plus We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. Company Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk. Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R D, from early research through late-stage clinical development. We are building for the future by creating a distinct R D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients. CONNECT Company info