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Operations Sampling Technician I - API

Employer
Novo Nordisk
Location
Clayton, NC
Start date
Nov 25, 2024
View more categoriesView less categories
Discipline
Manufacturing & Production, Operations
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC, Best Places to Work

Job Details

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

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

 

Relationships

Reports to Manager, Supply Chain & Logistics Support.

 

Essential Functions

  • 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 logbooks & 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
  •  

    Physical Requirements

    Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 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. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

     

    Qualifications

  • High school graduate or equivalent required
  • Minimum of one (1) year of experience operating in a GMP regulated environment preferred
  • Basic laboratory, sampling aseptic & ID testing techniques required
  • Knowledge of US, EU regulations & guidelines in reference to classified areas, sampling plans & methods & application of GMP’s a plus
  • Ability to communicate technical information clearly in writing & presentations preferred
  • Demonstrated experience in practical problem solving & process improvements a plus
  • Ability to read, write & understand product documentation & standard operating procedures with attention to detail & computer literacy required
  • Experience in LIMS system a plus
  • Experience planning, organizing, managing execution, checking results & revising work plans a plus
  •  

    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.

    Company

    Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    United States

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