Operations Sampling Technician I API

Facility:  Quality
Location: 

Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.

 

Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!

 

Position Purpose

Support all daily activities of a cGMP warehouse operation including inspection, sampling, sample management, shelf-life expiry inventory, Job Instructions (JI) & regulatory compliance.

 

Accountabilities

  • Follow all safety & environmental requirements in the performance of duties
  • Follow Standard Operating Procedures in performance of assigned duties
  • Partner with QC, QA, EM & support groups to ensure raw material release for production & resources to support schedules and enable the process to run optimally
  • Maintaining CNC areas & performing routine cleanings and batch turnover
  • Environmental Compliance
  • Complete all paperwork in a cGMP compliant manner
  • Continuous improvement/streamline processes
  • Ensure compliance with training programs & confirmation processes
  • Support validation & project activities as required
  • Sampling of Raw Materials from Bulk tankers, Pressurized Containers & Palletized Material
  • Manage individual training plan
  • Record/review log books & other associated forms/paperwork for the team. Ensure all errors are addressed & corrected real time ensuring compliance with cGMPs
  • Package samples for transport
  • Other accountabilities, as assigned

 

Required Qualifications

  • High school graduate or equivalent
  • Basic laboratory, sampling aseptic & ID testing techniques
  • Ability to read, write & understand product documentation & standard operating procedures with attention to detail & computer literacy

 

Desired Qualifications

  • Minimum of one (1) year of experience operating in a GMP regulated environment
  • Knowledge of US, EU regulations & guidelines in reference to classified areas, sampling plans & methods & application of GMP’s
  • Ability to communicate technical information clearly in writing & presentations
  • Demonstrated experience in practical problem solving & process improvements
  • Experience in LIMS system
  • Experience planning, organizing, managing execution, checking results & revising work plans

 

Physical & Other Requirements

  • Ability to work at a computer stationary for extended periods of time
  • Ability to stand on feet up to 8 hours or longer
  • Ability to work in & around an active construction site
  • Operational Phase:
    • Ability to move & work throughout the facility in the performance of duties in proximity to process equipment, ambient & cold classified areas, odors/hazardous materials, operating equipment & in moderate to loud noise environment
    • Ability to work flexible hours to support the international delivery team
    • Able to work hours as needed to support production including on call, some evenings and/or weekends
    • Ability to wear a respirator to perform job duties
    • Able to routinely operate & inspect equipment
    • Able to work in outdoor weather conditions
    • Able to perform critical job functions in extremely cold work environments
    • Able to work atop elevated positions at heights
    • Able to frequently move about the building/facility to access other personnel & operational areas
    • Ability to move equipment and or supplies weighing up to 50 pounds within facility
    • Corrected vision to 20/30 and/or ability to pass vision screening assessment 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.