Address
Form of workAbout 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 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 Emerging Technologies - Oral Finished Products 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. OFP 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 12 weeks paid parental & 6 weeks paid family medical leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Tuition Assistance – reimbursement up to 10k annually
- 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. 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.
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
- Making the stability pulls
- 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 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
- BS/BA 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 required
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.
