Quality Control Process Technical Analyst

About the Department

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 approximately 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 this by rethinking our production facilities with modern technology, setting the standards for the aseptic production of the future. Facilities designed today will still be a source of pride 20 years from now. FF Expansions has a global approach, where you will work with multiple sites and cultures across the world.

Responsibilities

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

Physical Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
• Ability to do close precision work with hands.
• Must be able to remain in a stationary position (sitting and standing) 50% of the time.
• May require 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 and/or hazardous materials.

Requirements

• Bachelor’s degree in science or technical field from an accredited university required, or equivalent combination of education and experience.
• May consider an Associate Degree in science or technical field from an accredited university 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, and products associated with assigned areas required.
• Perform detailed analysis of events and processes, develop appropriate responses to situational needs, and convey information/results to various organizational levels as appropriate required.
• Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train and coach others within the department and organization preferred.
• Knowledge and understanding regarding departmental processes and their high-level inter-relationships required (i.e., how they work together to establish a system).
• Excellent verbal and written communication skills, investigative writing skills, and computer skills (MS Word, Outlook, Excel, PowerPoint, and LIMS) required.
• Demonstrates ability to manage multiple tasks/deadlines and prioritize properly based on process needs and events required.

Benefits

• Leading pay and annual performance bonus for all positions.
• 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 and 6 weeks paid family medical leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.
• Tuition Assistance.
• Life and Disability Insurance.
• Employee Referral Awards.