What are the responsibilities and job description for the Quality Assurance Area Specialist I position at Novo Nordisk?
Quality Assurance Area Specialist I
Facility: Quality
Location:
Durham, NC, US
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 14 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. This position works closely with production. The schedule is Monday - Thursday working 10hr day shift schedule.
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.
