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Process Monitoring Leader
Ref No.: 16-00363
Location: Swiftwater,, Pennsylvania
Background:

The position is responsible for providing Manufacturing Technology Process Monitoring leaders with process data collection, updated control charts and Out-Of-Trend investigations. Also providing support for Design of Experiment activities.

Scope of work:

Typical scope of work required to support AP&T and other platforms in M Tech in:
  • Providing trend analysis for critical quality attributes, critical process parameters and in-process data
  • Participate in periodic reviews of critical quality attributes, critical process parameters and in-process data
  • Provide investigation, root cause analysis and product impact analysis for out of trend (OOT) data
  • Communicate product improvements/quality risks resulting from trend investigations to platform, production and quality
  • Participate in evaluation, analysis and implementation of changes to approved process monitoring parameters including report authoring and change control management
  • Provide Statistical Process Control for analytical methodologies for Assay trending
  • Provide support for Design of Experiment activities including study design and results interpretation.

Expectations:
The background for this position is :
  • Cooperate transversally and participate in cross functional teams to complete trend evaluations and product reviews
  • Work closely with other members of the department to share knowledge and competencies to help ensure timely completion of project deliverables
  • Generate reports on evaluation of process robustness and recommendations for improvements
  • Facilitate implementation of change management actions required as a part of process monitoring program including deviations, change controls and CAPA management
  • Critically analyze data from complex systems and recommend efficient courses of action for resolution or improvement
  • Comply with cGMP and other internal and external quality and regulatory guidance
  • Understand vaccine manufacturing
  • Proficient with statistical analysis and statistical software; ie. JMP, SAS, Minitab, Statistica, etc.
  • Proficient in MS Office (Excel, Word and Power Point ) 2010

Skills:
  • Proficient with statistical analysis and statistical software; ie. JMP, SAS, Minitab, Statistica, etc.
  • Proficient in MS Office (Excel, Word and Power Point ) 2010

Education: Master's degree in statistics or a Master's degree in biology with at least 3-5 years statistical process control experience and/or statistics