Quality Assurance Area Specialist I - Customer Complaints

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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 legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

 

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

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

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. Requires corrected vision to 20/20. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections• st be able to work with potentially infectious materials & bloodborne pathogens, needles & broken or cracked glass associated with processing used insulin products.

 

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

 

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 pos