Quality Assurance Area Specialist I, Customer Complaints

About the role

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?

Responsibilities

• Timely review, approval & closure of Internal/Customer complaints for all products marketed in the US and/or manufactured/packaged at IFP Clayton.
• 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.

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
• 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
• 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