Title is Process Monitoring Leader
This position is not currently on the rate card- max bill rate is (USD)130/hr.
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
Languages:English Read Write Speak
Attachments: •
Last updated on May 16, 2016