Quality Assurance Area Specialist I - OFP

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 - Oral Finished Products 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. OFP 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

Manager, Quality Assurance.

 

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
• This position works Monday - Thursday 10hr day shift.

 

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 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
• Keeps relevant people informed of current & future plans

 

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 tha