Quality Assurance Area Specialist I, Customer Complaints

Novo Nordisk•Clayton, NC

2d•Onsite

About The Position

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference? The Position Timely review, approval & closure of Internal/Customer complaints for all products marketed in the US and/or manufactured/packaged at IFP Clayton. IFP Clayton acts as the shipping hub for all of North America accounting for a high volume of samples requiring decision making.

Requirements

High School Diploma (GED) required
Demonstrated expertise in Good Manufacturing Practice (GMP) regulations & investigational skills (e.g. root cause analysis & systematic problem solving) preferred

Nice To Haves

Bachelor’s degree in life sciences or related field from an accredited university preferred
Two (2) years of Quality Assurance and/or related experience in the pharmaceutical or medical device industry preferred
Knowledge of Novo Nordisk products preferred
Working knowledge of Novo Nordisk production processes & products preferred
Expert knowledge of US, EU regulations & guidelines & ISO standards preferred
Excellent written & verbal communication skills preferred
Excellent computer skills in MS Office, MS Project, PowerPoint, etc preferred
Experience in the use of practical problem solving & LEAN tools preferred

Responsibilities

Support, review & approve complex cross-functional investigations related to Internal/Customer Complaints
Open packages and making decisions regarding the actions needed to complete investigations
Complete testing of samples as needed to confirm complaint
Write of Local Investigated Complaints and inspection of products to identify how they should be investigated
Ensure adequate standards for the processing of Internal/Customer Complaints
Ensure timely review, approval & closure of Internal/Customer Complaints including corrective & preventive actions
Ship samples to Corporate Customer Complaints (CCC) as needed
Initiate, respond, react and maintain customer complaint logs between IFP, NNI and CCC
Follow all lean principles while conducting daily business including LSW, 5S, SPS and Kata
Follow all safety & environmental requirements in the performance of duties
Other accountabilities, as assigned

Benefits

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health.
For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives.
This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare.
We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose.
Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations.
When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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.