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Job Description
The incumbent provides support for Supplier Quality Management activities of device components, active pharmaceutical ingredients (API), excipients, chemical raw materials, components, and packaging...
...regulatory industry, to lead a Process Excellence Program of the site.
Duties:
Leads continuous improvement and... ...other activities.
Support capability building efforts (ie. Lean Management basics and techniques).
Supports and leverages benchmarking...
...regulatory industry, to lead a Process Excellence Program of the site.
Duties:
Leads continuous improvement and... ...other activities.
Support capability building efforts (Lean Management basics and techniques).
Supports and leverages bench marking...
...and identifies significant trends.
Regularly reports them to management and appropriate cross functional teams.
Provides advanced... ...Equivalent
Work Methodology:
~ Hybrid: (Janssen- Gurabo, PR site) & remote.
~8 months (1st contract)
~ All shifts that worker...
...Responsible for configuration and simulation on Checklyst Manager application (prototypes and reports). Must have knowledge of databases... ...Identify new process improvement and necessities for Client’s Site to share information with Global Team.
Write assessments and...
...Water chemistry tests
~Execute preventive maintenance, troubleshooting and general repair work on specific assigned working area/site of mechanical, electrical system and equipment.
~Perform effectively inspections, testing and emptying secondary containment systems...
...Microbiology.
Generally Requires 2-4 years.
Preferred Qualifications:
~ Must have experience in parenteral area.
Work Methodology:
~ Full time on-site job
~2nd or 3rd work shift (subject to changes based on project needs)
~8 months of initial contract...
...these records.
Provide updates to Supplier Records on behalf of account owners.
Complete Supplier data for metrics and risk management documents.
Support Supplier Quality projects as needed.
Establish and process information for supplier updates in SAP (...
...Experience in Calibration system assessment
Strong knowledge in process tolerance evaluation.
Process Instrumentation/ Calibration to manage calibration program.
Experience performing calibrations to Bioreactors, Utilities, Formulation, Aseptic Areas.
Experience in...
...Protocols and Summary Reports
~Standard Operating Procedures
~ Impact/Risk Assessments
~Ensure that all chemicals are properly managed, from the moment a new chemical is requested for purchases or manufacture, by establishing, implementing, and maintaining a...