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QA Area Specialist I - OFP

Employer
Novo Nordisk
Location
Durham, NC
Start date
Oct 9, 2024
View more categoriesView less categories
Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC, Best Places to Work

Job Details

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

 

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

Ensures Batch Production Records (BPRs) & relevant quality processes are compliant with regulations. Performs quality review & approval of Change Requests (CR's) & other documentation (in conjunction with LoB). Performs archiving duties and QA presence & process confirmation on shop floor.

 

Relationships

Reports to Manager, QA.

 

Essential Functions

  • Ensures site compliance with Regulations, ISO standards, corporate & local SOPs
  • Reviews & approves documentation for Quality approval – batch records & other documentation
  • Supports & reviews investigations & root-cause analysis
  • Participates in process confirmations & Go Look Sees
  • Follow all safety & environmental requirements in the performance of duties
  • Other accountabilities, as assigned
  •  

    Physical Requirements

    May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.

     

    Qualifications

  • Bachelor’s degree in life sciences or related field of study from an accredited university required
  • With P&O review/agreement, equivalent combination of education and internal NN business/operational experience may be substituted for degree as appropriate
  • Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the pharmaceutical or medical device industry
  • General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred
  • General knowledge of quality oversight & on floor production support preferred
  • Good written & verbal communication skills required
  • Basic computer skills in MS Office, PowerPoint, Word, Excel, etc. required
  • Knowledge of cGMPs in manufacturing required, pharmaceutical manufacturing preferred
  • Knowledge of Quality & Production processes required
  • Sets goals & prioritizes tasks for own work on short-term basis, meets deadlines & makes regular progress reports on performance
  • Keeps track & informs management about fluctuation in workload
  • Performs well with multi-tasking
  • Adjust priorities in accordance with changing circumstances
  •  

    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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