Quality Assurance Area Specialist I, Customer Complaints

About the Department

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. Were 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.

Relationships

Reports to Manager.

Essential Functions

• 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

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

Qualifications

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

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve 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 whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Required Experience:

IC