QA Area Specialist IT/OT

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

Ensures plant systems batch release & other relevant quality processes are compliant with regulations e.g.: 21CFR part 211. Has product release authority (Authorized Qualified Person), if role is in batch release. Serve as Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems & maintaining validated state of equipment, processes, and systems. Serve as the Finished Product (FP) Process Representative or Site Clayton Process Representative as assigned. Serve as a FP subject matter expert for QA processes & drives improvement activities based on process performance, event response & process confirmation across FP, utilizing LEAN principles.

 

Relationships

Senior Manager, Quality Assurance.

 

Essential Functions

• Make decisions on quality & compliance issues with little guidance
• Participate in process group activities as assigned & leads local implementations
• Ensure site compliance with Regulations, ISOISP standards, corporate & local standard operating procedures (SOPs)
• Serve as the Subject Matter Expert (SME) of the multiple quality processes
• Lead improvement activities/improvement of standards within the assigned process
• Lead & coordinates batch release activities
• Leads large scope tasks that demand project teams & compliance resource management skills
• Provide coaching to Site regarding quality & compliance related activities
• Support, review & approve complex cross-functional investigations & root-cause analysis
• Facilitate sharing of regulatory & compliance expectations
• Review & approves complex DVs, CRs, SOPs, trend & report data for CAPA, Quality Management Reviews (QMRs) & Annual Product Review (APR) reports
• Eliminate non-value-added practices
• Facilitate presentation, support & coaching for audits & inspections
• Serve as Quality work package owner, or Quality approver of validation documentation
• Review & approve complex Change Requests (CR's), Deviations(DVs), CAPAs & other documentation
• Perform Self Audits (in conjunction with line of business (LoB)); QA presence & process confirmation on shop floor
• Serve as Quality Risk Management Expert and responsible for development and leading and/or facilitating training
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, 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 20/20 or 20/25 based on role. May require color vision based on role.

 

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a relevant field of study from an accredited university required
• Minimum of ten (10) years of QA and/or related quality expe