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Project Area Specialist - Project Qualit Clayton United States,  

Novo Nordisk (company)

Posted on : 04 April 2017

Project Description

Job Description 
  • For more than 90 years, we have led the way in diabetes care. Being part of our company allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.
  • To help meet the growing demand for our diabetes treatment, our company  expects to double production of diabetes drugs over the next decade.
  •  The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.
  • Our company is currently seeking top talent for this green field project and eventual operations.
  • This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build.
  • Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

Position Purpose
  • Project Area Specialist in the DAPI-US Project.  
  • Experienced Project Area Specialist within project quality that can drive implementation of our company Quality Concept in the project work packages.

  • Build understanding of the DAPI-US Quality Concept.
  • Provide knowledge about HP Quality Center.
  • Support ad hoc tasks & challenges within Quality Concept & HP Quality Center.
  • Implement relevant work processes within the work package in DAPI-US project.
  • Alignment of work & quality processes within work packages.
  • Participation in alignment of work & quality processes.
  • Identify & implement improvements that support lean project execution.
  • Build strong relations to work packages in our company  project organization.
  • Responsible for training new employees in HP Quality Center modules.
  • Support one or more production/quality tracks (including but not limited to Warehouse, Automation, Fermentation, Purification, Recovery, &/or Site Services).
  • Support/advise employees with technical problem solving regarding HP Quality Center.
  • Maintain relevant activities in HP Quality Center.

BA/BS in related field or equivalent combination of education & experience combined with other relevant pharmaceutical technical education.

  • 5+ years of directly relevant work experience.
  • 3+ years of experience with facility & equipment validation.
  • Knowledge of electronic document validation system.
  • Understanding of lean project execution principles, continuous improvements & the application in a project environment.

Technical/Process/Functional Knowledge: 
  • Quality & validation experience.
  • HP Quality Center experience.
  • Project execution knowledge & the ability to link/translate validation procedures & principles to practical hands on project works processes.
  • Written & verbal communication skills to allow efficient interaction with all members in the work packages.

Physical & Other Requirements:
  • Ability to work in & around an active construction site during project phase.
  • Ability to work in confined spaces & near operating equipment.
  • Ability to work in loud noise environments.
  • Ability to travel internationally.
  • Ability to work flexible hours to support international delivery team.
  • Comfortable working independently. 


US Clayton NC

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