Quality Control Validation Area Specialist II at Novo Nordisk in Clayton, North Carolina

Job Description:

About the Department
At Novo Nordisk, we want to make a difference. For more than 95 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.Help us bring quality to life.Our filling and finishing facility (DFP) is a 457,000 square foot aseptic \\"fill and finish\\" manufacturing facility located in Clayton, NC and employs more than 850 people. The facility is part of a global network of manufacturing sites responsible for several key steps in the diabetes treatment manufacturing process, including sterile formulation, filling, inspection, device assembly and packaging.Producing medicines is a special responsibility. Our employees are passionate about what they do, knowing that their work makes a difference to millions of people who rely on our products every day.Are you ready to make a difference?

Position Purpose
Plan, manage & perform laboratory validation activities. Handle complex or cross functional validation projects. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for Quality Control (QC) equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.

Accountabilities
- Accuracy & compliance of validation & equipment records
- Validation responsible for QC equipment & instrumentation
- Identify & handle deviations per proper appropriate procedures
- Maintain good standing with stakeholders through engagement & positive cooperation
- Perform & oversee change control activities for QC equipment & systems
- Validation process SME for the QC areas
- Other accountabilities, as assigned

Required Education
BS/BA Degree in Life Sciences, Chemistry, Engineering, or a relevant combination of education & experience

Required Experience
Minimum of five (5) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field.

Desired Experience
- Experience writing & executing validation protocols
- Experience managing projects

Technical/Process/Functional Knowledge
- Working knowledge of Good Manufacturing Practices (GMPs)
- Ability to act as project manager driving & implementing equipment projects
- Demonstrated ability to write & present technical/scientific documents & reports
- Understanding of QC equipment/systems, end user functionality, & life-cycle management

Organization/Planning
Demonstrated ability to manage multiple projects & competing priorities.

Physical & Other Requirements
- Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
- Constantly operates a computer & other office equipment using hands
- Able to work in an open office environment with the possibility of frequent distraction
- Able to work the hours necessary to support a 24/7 continuous manufacturing operation

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications..