Novo Nordisk Clayton , NC 27527
Posted 2 days ago
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 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 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 12 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
Main 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.
Relationships
Manager, Quality Assurance.
Essential Functions
Perform activities related to Batch review
Review 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 minor change control requests & low complex major change controls
Review & approve minor deviations & low complexity major deviations
Provide 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
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, Engineering, or related field or equivalent combination of education & work experience required
Minimum of three (3) years of QA or related experience in the pharmaceutical or medical device industry preferred
Understanding of cGMP manufacturing & production processes & how to apply required
Understanding of the Batch review Processes preferred
Understanding of quality management systems preferred
Understanding of quality oversight & on floor production support preferred
Strong written & verbal communication skills required
Strong computer skills in MS Office, PowerPoint, Word, Excel, etc. required
Understanding of cGMPs in pharmaceutical manufacturing required
Understanding of Quality & Production processes required
Good stakeholder relations required
Capable of prioritizing & managing workload 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.
Novo Nordisk