Support NPI QC Testing on PSBs, Clinical, PPQ, Demo and investigational lots via Cell Based Potency Assay and related [LISA methods.
Timely review of testing records and all associated documentation.
Routine lab duties including critical reagent qualifications, inventory management and equipment maintenance.
Perform all activities are completed in line with regulatory (QA and HS) and corporate requirements.
Open and progress QMS records as required – Laboratory Investigations, Change Controls
Complete assigned training on time
Understand regulations and business processes required to maintain laboratory data integrity
Provide input on assay performance monitoring and trending
Supporting Root Cause Analysis Investigations
Attend departmental and Tier meetings
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Pay Range: $-
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.
Tagged as: Life Sciences
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