Quality Assurance Area Specialist I Or Ii

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 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:

• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Leading pay and annual performance bonus for all positions
• Tuition Assistance – reimbursement up to $10,000 annually
• Employee Referral Awards
• Guaranteed 8% 401K contribution plus individual company match option
• Free access to Novo Nordisk-marketed pharmaceutical products
• All employees enjoy generous paid time off including 14 paid holidays
• Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
• Life & Disability Insurance

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.

Position Purpose

Ensures Batch Production Records (BPRs) & relevant quality processes are compliant with regulations. Quality review & approval of Change Requests (CR’s), Deviations & other documentation. Performs Self Audits (in conjunction with LoB), QA presence & process confirmation on shop floor.

Accountabilities

• Evaluates trend & report data for QMRs & APR reports
• Other duties, as assigned
• Participates in process confirmations & Go Look Sees
• Ensures site compliance with Regulations, ISO standards, corporate & local SOPs
• Reviews & approves documentation for Quality approval – batch records, deviations & other documentation
• Supports, reviews & approves investigations & root-cause analysis

Desired Qualifications

• General knowledge of regulations & quality systems (e.g. product disposition, NC/CAPA, Change Control, Audits, Supplier Management, Project Management, etc.)
• Excellent written & verbal communication skills
• Knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs in aseptic manufacturing
• Minimum of 2 years of QA and/or quality related experience in the pharmaceutical or medical device industry with progressively increasing responsibility
• Knowledge of Quality, Aseptic Production, Business Support, QC, O&P and/or Finished Production processes
• BA/BS degree in life sciences or related field, or an equivalent combination of education & experience
• Personal Time Management: 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. Keeps relevant people informed of current & future plans
• Familiarity with local processes & quality systems
• Basic computer skills in MS Office, MS Project, PowerPoint, etc.

Physical & Other Requirements

• Able to work the hours necessary to support a 24/7 continuous manufacturing operation
• Some roles require ability to work 12 hour shifts or longer, day or night
• Able to work in an open office environment with the possibility of frequent distraction
• Able to travel domestically and/or internationally, as necessary
• Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
• Able to adjust schedule to work with colleagues in other international time zones

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.