Job Description
About the Department
At 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 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 the production activities & validation. Ensures relevant compliance issues are addressed & handled in close collaboration with production. Main duties include review of batch reports & release of API materials, deviations, change controls, review & approval of SOPs, QA presence & process confirmation on shop floor & improvement of Quality processes.
Relationships
Reports to Manager, Quality Assurance.
Essential Functions
- Ensure that the current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions
- Support validation projects in communicating Novo Nordisk project quality requirements & assessing suppliers' ability to support test/qualification activities to ensure that Novo Nordisk requirements & expectations are clear
- Support projects in solving quality related issues, act quickly in order to come to a decision, & communicate quickly & clearly regarding such decisions
- Support evaluation of the quality level during the project by performing spot checks of validation documentation
- Perform activities related to Batch review & release
- Review & approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
- Ensure site compliance with Regulations, ISO standards, & Corporate/Local SOPs
- Review & approve change control requests
- Review & approve deviations
- guidance to departments regarding quality & related activities
- Participate & provide input to root-cause analysis
- Participate in process confirmations & quality oversight
- Authorized person according to Novo Nordisk Quality Manual
- Other accountabilities, as assigned.
Physical Requirements
May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require colour vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications
- Bachelors Degree in Life Sciences, Engineering, or related field required
- Minimum of five (5) years of experience within the pharmaceutical industry required
- Good Knowledge of cGMP manufacturing & production processes & how to apply required
- Good Knowledge of the Batch review Processes required
- Good Knowledge of quality management systems required
- Good Knowledge of quality oversight & on floor production support required
- Strong knowledge level in cGMP's & validation required
- Strong knowledge in Quality Management Systems required
- Must be ability to perform tasks independently, accurately & within defined time frames required
- Ability to willingly work with customers/stakeholders in a cooperative manner required
- Strong written & verbal communication skills required
- Strong computer skills in MS Office, PowerPoint, Word, Excel, etc required
- Proven expertise in planning & organizing tasks preferred
- Willingness to assist others in developing plans in a cross-functional environment preferred
- Innovative approach to establishing priorities preferred
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, were not chasing quick fixes - were creating lasting change for long-term health. For over 100 years, weve 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 whats possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, were 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.
Numbers & Facts
| Location | Clayton, NC |
| Industry | Biotechnology/Pharmaceuticals |
| Company Size | 2,500 to 4,999 employees |
| Year Founded | 1923 |
| Website | https://www.novonordisk.com/ |
About Company
Working at Novo Nordisk
Life-changing careers
Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.
Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.
We are inspired by life
We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.
We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.
Together we drive change
Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.
We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.
Together, we are life-changing
Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.
Your development starts here
We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.
It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile.
With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.
In the video above, meet Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.
Who we are
We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, 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 diabetes.
With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.
Skills
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