Posted to MedZilla on 7/21/2018


Novo Nordisk

US-NC, Process Area Specialist - QC Job 487220900A0-MZ


 
 

Position Purpose:
  • Maintaining & making improvements to the Production Environmental Monitoring (PEMS) system including performing changes related to the Master Data.
  • Perform investigations of EM Excursions.
  • Completion of PEMS batch reports.

Accountabilities
Responsible for the following duties:
  • Developing & performing training on aseptic concepts.
  • Identifying aseptic process needs & improvement opportunities.
  • Performing root cause analysis investigations for environmental excursions through use of SPS tools.
  • Ensuring timely completion of EM investigations.
  • Performing process confirmations to ensure compliance and process improvements.
  • Generating PEMS reports to support batch release activities.
  • Training on PEMS, aseptic concepts & EM sampling techniques.
  • Ensuring department documents are current & standardized.
  • Perform other duties as required.

Education:
BS/BA in life sciences, engineering, computer science, or related field or equivalent combination of education & experience.

Experience:
  • 3+ years of aseptic manufacturing experience in a pharmaceutical environment.
  • Environmental Monitoring experience preferred.
  • Strong working knowledge of database management systems.

Technical/Process/Functional Knowledge:
  • Ability to read, write & understand standard operating procedures with attention to high-level concepts.
  • Computer literacy.
  • Ability to drive continuous improvements via Lean tools & Six Sigma methodologies.
  • Knowledge of Aseptic conduct and behaviors in a pharmaceutical environment.

Organization/Planning:
Proven expertise in planning/organizing, managing execution, checking results & revising plans.

Physical & Other Requirements:
  • Ability to attain clean room gowning certification.
  • Ability to work with hazardous materials including sanitants.
  • Ability to work near operating equipment.
  • Ability to travel internationally.
  • Ability to work hours necessary to support production.


Requisition ID: 57569BR
State/Provinces: Clayton
Job Category: Quality


Please visit our website at www.novonordisk.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.