QC Regulatory & Stability Area Specialist

QC Regulatory & Stability Area Specialist Novo Nordisk - 4.1 Durham, NC Job Details 1 day ago Benefits 401(k) 8% Match Paid holidays Disability insurance Health insurance Dental insurance Tuition reimbursement Paid time off Parental leave Vision insurance 401(k) matching Qualifications Laboratory sample storage Stability testing Stability studies in drug product development Laboratory information management systems Mid-level Technical report writing Trend analysis Quality control audit Quality reports Laboratory reports Bachelor's degree Scientific protocols Quality improvement Chemistry Regulatory submission editing and review Computer skills Quality control within pharmaceutical industry Quality control communication Training Pharmaceutical product quality management Communication skills Editing Bachelor's degree in chemistry Audit support Laboratory compliance and regulatory documentation Scientific reports

Full Job Description QC Regulatory & Stability Area Specialist Facility:

Quality Location:

Durham, NC, US 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 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 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 Responsible for supporting the stability & retain programs for Quality Control site. Support process & drive improvement activities based on process performance, event response & process confirmation. Ensures audit readiness & shares ideas & solutions with other departments & sites. Relationships Reports to Manager, Quality Control Support. Essential Functions Responsible for preparing & updating stability protocols & reports Trend stability data & initiate trend investigations Responsible for providing stability & retain reports to corporate for annual product reviews Track & ensure stability testing is completed on time Write stability documents to support regulatory submission for new products Write stability documents for all other regulatory requests Support LIMS builds & training Maintain stability & reference sample inventory (storage & discard of samples) Stability representative during audits/inspections Project team member for new product transfers Other duties 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 Chemistry or related scientific field preferred or equivalent education & experience required Minimum of two (2) years of experience with stability programs &/or regulatory relevant experience preferred Strong communication skills (verbal & written) & the ability to author scientific & technical reports preferred Must demonstrate attention to detail, proofreading & strong computer skills with a willingness to learn new IT applications preferred Ability to control all aspects of the stability & retain programs a plus We 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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.