Senior Quality Assurance Area Specialist I Automation

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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 newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products.  At API, 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

Design & develop quality & compliance set-up for the Automation process during the project. Monitor Automation work package for relevant quality related issues. Ensure compliant execution & monitoring. Drive corrective actions & quality improvement initiatives within Automation work package.

 

Relationships

Manager, Quality Assurance Validation.

 

Essential Functions

• Oversee & approve User Requirements for assigned process
• Review & Approve Batch Documentation
• Formulates continuous improvement tools for QA Compliance operations
• Ensure compliance with Regulations, ISO standards & corporate & local SOPs
• Develop & implement metrics for Quality System process improvements
• Prepare & approve documents regarding QA department’s related activities
• Support, review & approve cross-functional investigations & root-cause analysis
• Review & approve validation & change control documentation
• Ensure quality & compliance with company procedures, policies & objectives
• Reporting of project performance to the relevant stakeholders
• Perform other duties as assigned

 

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

• BA/BS in Engineering or other related IT/Automation field required
• Minimum of five years of chemistry, validation or engineering experience in the pharmaceutical industry or related field required
• Minimum of three years of software validation (CSV) experience preferred
• GMP experience required
• Experience reviewing & approving validation protocols required
• Experience managing projects preferred
• Experience in software lifecycle management required
• Specialist in assigned processes required
• Solid network within PS & related areas within NN or strong Pharmaceutical Industry experience required
• General knowledge of Six Sigma or LEAN (cLEAN®) principles required
• General knowledge of US, EU regulations & guidelines, ISO standards & application of GMPs within Automations required
• Good stakeholder management & change management skills.  Strong in setting direction & describing framework. Solid structural & follow up skills 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