Posted to MedZilla on 7/14/2018

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.

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.

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

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

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