Quality Control Analyst I or II

Facility:  Quality
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we want to make a difference. For nearly 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 legacy Injectable Finished Products (IFP) 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 IFP, 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 – reimbursement up to $10,000 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.

Position Purpose

Perform & review analysis of in-process, release & stability samples of API &/or filled product in accordance with cGMP, site & corporate procedures & policies. Transfer of technology & processes in accordance with relevant project plans & timelines. This is a Quality Control chemistry laboratory group focusing on incoming raw materials.

 

Accountabilities

  • Accuracy & Scientific Soundness of Lab Data
  • Environmental Compliance
  • GMP Compliance of Laboratory
  • Maintain testing proficiency for methods
  • Timeliness of Lab Results & Investigations
  • Analysis of Samples
  • Supports Deviations
  • Other accountabilities, as assigned

 

Desired Qualifications

  • BA/BS in a science or related field of study
  • Minimum of one (1) year of experience in a clinical or industrial/pharmaceutical laboratory
  • Ability to author scientific & technical reports
  • Able to perform routine testing per SOP & GMP standards
  • Basic troubleshooting for laboratory equipment
  • Knowledgeable in GMP & laboratory techniques
  • Must demonstrate attention to detail
  • Strong communication skills (verbal & written)
  • Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis)
  • Ability to execute testing according to a structured plan

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds, using various body positions
  • Ability to perform close precision work with hands
  • Ability to remain in a stationary position up to 50% of the time
  • Corrected vision to 20/30 & ability to see all colors
  • Occasionally ascends/descends a ladder to take samples
  • Occasionally works around odorous and/or hazardous materials
  • Ability to attain clean room gowning certification
  • Ability to work with hazardous materials & chemicals, including sanitants
  • Ability to work near operating equipment
  • Able to move throughout the facility to interact with other employees in the normal office & manufacturing environment
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation
  • Able to adjust schedule to work with colleagues in other international time zones
  • Able to travel internationally, if necessary

 

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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.