Quality Control Validation Area Specialist I

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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.

Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.

Reports to Manager.

• Accuracy & compliance of validation & equipment records
• Validation responsible for QC equipment & instrumentation
• Maintain good standing with stakeholders through engagement & positive cooperation
• Perform & oversee change control activities for QC equipment & systems
• Follow all safety and 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 Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university required
• May consider Associate's Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of four (4) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
• Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
• Experience in managing projects preferred
• Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus
• Working knowledge of GMPs required
• Ability to act as project manager driving & implementing equipment projects required
• Demonstrated ability to write & present technical/scientific documents & reports preferred
• Understanding of QC equipment/systems, end user functionality & life-cycle management a plus

We commit to an inclusive recruitment process and…