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Quality Control Analyst I

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 Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  
 
Our Clayton, NC Diabetes Finished Products (DFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at DFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging. 
 
At DFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility. 
 
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.

 

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

 

Education

BA/BS in a science or related field of study.

 

Experience

Minimum of one (1) year of experience in a clinical or industrial/pharmaceutical laboratory.

 

Technical/Process/Functional Knowledge

  • 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)

 

Organization/Planning

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
  • Novo Nordisk requires all employees to be fully vaccinated with a COVID-19 vaccine by December 8, 2021.  As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.

 

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.