Quality Assurance Area Specialist - Validation

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 newer Oral Finished Products (OFP) tableting facility in Durham, NC sits on 194,000 square feet of state-of-the-art equipment and supports the production of our innovative oral treatments for patients with type 2 diabetes. Employees work across Bulk Production, Packaging, Warehouse, Business Support, QC and QA. At OFP, you’ll join a global network of manufacturing professionals who are passionate about what they do and committed to helping us meet the growing demand for our treatments.

What we offer you:

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

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. 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.

Accountabilities

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

Required Qualifications

• Good written & verbal communication skills required
• With P&O review/agreement, equivalent combination of education and internal NN business/operational experience may be substituted for degree as appropriate
• Basic computer skills in MS Office, PowerPoint, Word, Excel, etc. required
• Minimum of one (1) year of QA and/or cGMP related experience required, preferably in the pharmaceutical or medical device industry
• Knowledge of Quality & Production processes required
• Bachelor’s degree in life sciences or related field of study from an accredited university required

Desired Qualifications

• General knowledge of quality oversight & on floor production support preferred
• Performs well with multi-tasking
• Adjust priorities in accordance with changing circumstances
• Keeps track & informs management about fluctuation in workload
• Sets goals & prioritizes tasks for own work on short-term basis, meets deadlines & makes regular progress reports on performance
• Knowledge of cGMPs in manufacturing required, pharmaceutical manufacturing preferred
• General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred
• Keeps relevant people informed of current & future plans

Physical & Other Requirements

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

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.