Job Information
Novo Nordisk Quality Control Analyst III - Microbiology in Clayton, North Carolina
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 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
Perform & review analysis of in-process, release & stability samples of API and/or filled product in accordance with cGMP, site & corporate policies & procedures. Transfer of technology & processes in accordance with relevant project plans & timelines. Provide leadership for other analysts as they execute their daily tasks.
Relationships
Manager.
Essential Functions
Ensure accuracy & scientific soundness of lab data
Endure environmental compliance
Support & ensure GMP Laboratory Compliance
Maintain testing proficiency for methods
Ensure timeliness of lab results & investigations
Perform analysis of samples
Author deviations
Coach other analysts
Perform data trending & tracking
Develop process competence across IFP/API
Drive process improvement for Site QC
Ensure all Analyst testing of samples is complete, as needed
Ensure departmental documents are current & standardized
Perform Laboratory Equipment Validation & System support
Provide Laboratory IT System support
Leverage solutions to other NNPILP sites
Perform deviation & change control activities
Support other NNPILP sites when relevant
Support deviations
Participate in Systematic Problem Solving
Follow all safety & environmental requirements in the performance of duties
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 from an accredited university required
May consider an associate’s degree from an accredited university with seven (7) years of relevant experience in a clinical or industrial/pharmaceutical laboratory required
Five (5) years of experience in a clinical or industrial/pharmaceutical laboratory required
Ability to author scientific & technical reports required
Able to perform routine testing per SOP & GMP standards required
Change control, deviation, trending preferred
Advance level knowledge in GMP & laboratory techniques required
Demonstrate attention to detail required
Project Management experience is a plus
Serve as a subject matter expert on QC processes required
Strong communication skills (verbal & written) required
Advanced level of troubleshooting for laboratory equipment preferred
Validation & technical transfer experience preferred
Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, PH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis) 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.