Company

BiospaceSee more

addressAddressClayton, NC
type Form of workFull time
CategoryInformation Technology

Job description

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 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
  • 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

Quality Control Manager.

 

Essential Functions

  • Data Trending & Tracking
  • May Participate in Process Groups
  • Accuracy & Scientific Soundness of Lab Data
  • Environmental Compliance
  • GMP Compliance of Laboratory
  • Maintain testing proficiency for methods
  • Timeliness of Lab Results & Investigations
  • Coaching other analysts
  • Develop process competence across DFP/DAPI
  • Drive or participate in event response activities on own site
  • Drive process improvement in Site Clayton QC
  • Ensure departmental documents are current & standardized
  • Laboratory Equipment Validation & System support
  • Laboratory IT System support
  • Lead Lab Projects & Product Transfer Projects
  • Leverage solutions to other sites in DFP/DAPI
  • Perform deviation & change control activities
  • Support other DFP/DAPI sites when relevant
  • Systematic Problem Solving
  • Work independently with minimal supervision
  • 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 in a scientific field or equivalent combination of education & relevant experience required
  • Minimum of five (5) years of experience in a clinical or industrial/pharmaceutical laboratory preferred
  • Ability to author scientific & technical reports preferred
  • Ability to perform routine testing per SOP & GMP standards preferred
  • Change control, deviation & trending required
  • Knowledgeable in GMP & laboratory techniques preferred
  • Must demonstrate attention to detail preferred
  • Serve as a subject matter expert on QC processes preferred
  • Strong communication skills (verbal & written) required
  • Troubleshooting for laboratory equipment required
  • Validation & technical transfer experience preferred
  • Ability to execute testing according to a structured plan preferred
  •  

    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.

    Refer code: 9328843. Biospace - The previous day - 2024-05-30 02:25

    Biospace

    Clayton, NC
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