Quality Control Process Technical Analyst

Quality Control Process Technical Analyst

Facility:
Quality

Location:

Clayton, NC, US

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now.

FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

• 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 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Life & Disability Insurance

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.

Provides support to Quality Control (QC) by driving continuous improvement, optimization and innovation as well as leading systematic problem solving and change requests. Works with members of the departmental leadership team to share best practices with NN departments/sites & external vendors. Based on assigned area of responsibility, may work with LIMS and/or QC initiatives.

Reports to Manager, QC Support.

• Serve as QC Global LIMS Site Super User and QC Static Builder responsible for training and building of QC methods
• Responsible for driving continuous improvement, innovation and optimization projects
• Responsible for driving change requests and assisting with large scale investigations (QMT)
• Lead & coach peer analysts and leaders in problem solving for small-scale process & quality issues
• Understand the processes of data evaluation and trending, to include reporting findings to leadership
• Represent QC on global level and interact/collaborate with other NN sites
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

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 colour vision based on role. Occasionally ascends/descends a ladder.

May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.

• Bachelor’s degree in science or technical field from an accredited university required or equivalent combination of education and experience required
• May consider an Associate Degree in science or technical field from an accredited university required with a minimum of seven (7) years QC experience
• Minimum of five (5) years of QC experience in a pharmaceutical or related (regulated) environment required
• Leadership/Supervisory experience preferred
• Demonstrated foundational understanding of processes, procedures & products associated with assigned areas required
• Perform detailed analysis of events & processes, develop appropriate responses to situational needs & convey information/results to various organizational levels as appropriate required
• Demonstrated knowledge of adult learning methodologies & can use multiple methods…